510 Biostatistics Jobs - Page 8

Description Senior Medical Writer (CSR, IB , Protocol) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects Qualifications Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred 5 years of relevant experience in science, technical, or medical writing Experience working in the biopharmaceutical, device, or contract research organization industry required Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus Leading the clear and accurate completion of medical writing deliverables Managing medical writing activities associated with individual studies Coordinating these activities within and across departments Completing a variety of documents, adhering to established regulatory standards Coordinating quality and editorial reviews Acting as peer reviewers for the internal team Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs Performing online clinical literature searches and complying with copyright requirements Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentoring and leading less experienced medical writers on complex projects Developing deep expertise on key topics in the industry and regulatory requirements Working within budget specifications for assigned projects

Description Medical Writer II (Clinical Trial Transparency) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Description Sr Biostatistician - Biomarker (EMEA Remote) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Major tasks: Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statistician Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects Provides statistical input in clinical development discussions, and usage of AI and ML approaches. Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects Conduct and design advanced data analysis for genomics and biomarker statistics, including statistical programming, and design complex analysis algorithms. Experience with RNA, olink and other biomarker data handling experience Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results. Works independently at routine and complex statistical questions, modeling and tasks. Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments. Qualifications PhD or MSc in Biostatistics, Statistics or Mathematics, or related field Strong communication and interpersonal skills Ability to work independently as well as collaboratively, as required. Minimal supervision required. Usage of AI and ML approaches Previous experience in independently leading biomarker study mandatory Previous clinical trial experience, industry experience is preferred Strong knowledge on Biomarker evaluation, esp. In immunology and infections, type I diabetes, relevant parameters and underlying biology Good knowledge of statistical programming languages including R (Bioconductor package and other relevant R packages for genetic data), Python Analysis of high-dimensional data Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Hiring in select Europe countries only. Candidates must require no VISA sponsorship. This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. This project will focus on Biomarker data.

Job Title: Clinical Scientist & Operations Excellence Manager Location: Bangalore, HURC About Unilever Established over 100 years ago, we are one of the world’s largest consumer goods companies. We are known for our great brands and our belief that doing business the right way drives superior performance. We believe that the winning businesses of tomorrow will be those which anticipate and respond to the huge changes shaping people’s lives across the world. We are more certain than ever that it is the right time to focus our sustainability efforts on the four key priorities where we are best placed to drive impact: climate , nature , plastics and livelihoods . Background & Job Description Clinical research area is a strategic Capability for Unilever Research & Development (R&D). The Clinicals team at Bangalore is seeking a Clinical Scientist & Operations Excellence Manager to support their clinical programs. He / she will be responsible for the delivery of the clinical studies across HUL Foods within agreed timelines and budgets. Main Responsibilities There will be dual responsibilities of managing the clinical from an operations perspective as well as support as a clinical research scientist, including responsibilities for clinical design, proposal, governance, risk assessment and management. Specifically, the responsibilities include: Being responsible for clinical studies from scientific and operations perspective including internal / external CROs partnerships. Independent clinical management delivering a study on time in full (OTIF) and within budget. Contribute to scientific content during the process of designing, executing and interpreting clinical trials and results. Being capable of independently designing clinical trials, selecting potential CROs and putting plans in place for clinical execution. Coordinating with multiple cross functions (supply chain, procurement, NPD, legal, finance for ensuring smooth study contracts & agreements. Leading internal approvals for POs / payments etc, documentation along with leading operations and coordinating with 3Ps/CROs for clinical study execution. Ensuring timely product availability at clinical sites, study monitoring for compliance, and study reporting. Engage with cross functional teams to understand requirements with project teams and suggest suitable actions/study design. Ability to identify and flag potential issues and associated risks to clinical lead and proactively communicate with project team/s. To effectively coordinate all activities with 3P to conduct testing and reporting. Capture all relevant data, interpret, and support in writing the clinical study reports and manuscripts. Others This role will require innovative and creative thinking, as well as personal drive for clinical study execution. Able to adapt to changing needs of project and/or business. Knowledge of clinical design and a broad science base, with focus on Foods and Nutrition. Ability to recognize significance of unusual test results and how they lead to new clinical insights and technical opportunities; ability to handle & interpret data and communicate significance of what it means to teams. Fundamental knowledge of in market claims support Relevant Experience Master’s degree in clinical research / clinical data management with a minimum of 6-8 years of experience in Foods / FMCG industry. Candidates with a Foods & Nutrition background along with a CRO experience will also be considered. Experience in biostatistics and statistical analysis is additionally desirable. Our Commitment To Equality, Diversity & Inclusion Unilever embraces diversity and encourages applicants from all walks of life! This means giving full and fair consideration to all applicants and continuing development of all employees regardless of age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage and civil partnership, and pregnancy and maternity. "All official offers from Unilever are issued only via our Applicant Tracking System (ATS). Offers from individuals or unofficial sources may be fraudulent—please verify before proceeding."

Internal/extrernal stakeholders, project team members, vendors Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 3 years programming experience in industry recommended. For US positions: US military experience will be considered towards industry experience. Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs. Understanding of clinical data structure (e.g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e.g., MS office, XML. Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Preferred Requirments: Minimum of 3 years clinical / statistical programming experience within pharmaceutical clinical development Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience in other software packages (e.g. R) Experience with the Linux operating system IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Overview Recruiter - Full Life Cycle (Tech & Non-Tech | Life Sciences Focus) Location: Bengaluru, India (Onsite Monday through Friday) About Emmes: The Emmes Company, LLC (“Emmes”) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass. Our “Character Achieves Results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research. If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients’ success by sharing ideas openly and honestly. Primary Purpose: Emmes is looking for a full life cycle Recruiter who can support our diverse and expanding hiring needs across technical and non-technical functions , including clinical operations, data science, software engineering, business development, marketing, finance, and more. This role will be responsible for recruiting top talent at all levels , from early-career professionals to executive leaders. The ideal candidate brings strong recruiting fundamentals, the agility to work across domains, and a genuine interest in advancing health innovation. Experience in or exposure to the life sciences, CRO, biotech, or healthcare sectors is strongly preferred but we’re also open to those who have genuine interest in learning about our domain. Responsibilities Manage the end-to-end recruitment process for a wide range of roles across Emmes' global business. Partner with hiring managers to develop job descriptions, align on hiring strategies, and deliver qualified talent efficiently and thoughtfully. Source active and passive candidates using a variety of tools (LinkedIn Recruiter, job boards, referrals, and Boolean search). Hire across multiple disciplines, including: Technology: Software engineering, data science, product management Clinical Research: Biostatistics, clinical trial management, regulatory affairs Corporate Functions: Finance, HR, marketing, sales, and executive leadership Deliver a consistently positive candidate experience with timely, professional communication. Collaborate with HR and People teams to align on employer branding, workforce planning etc. Maintain accurate and organized data in the Applicant Tracking System (ATS) and generate reports on key recruitment metrics. Stay current on industry trends and labor market conditions, especially in the life sciences and clinical research ecosystem. Qualifications 3-5 years of full life cycle recruiting experience in an in-house and/or agency environment. Demonstrated success hiring across multiple departments and levels, including leadership roles. Demonstrated success hiring across multiple regions across the globe Strong sourcing and pipeline development skills across both technical and business functions. Effective stakeholder management, influencing, and communication skills. Comfortable working in a fast-paced, mission-driven, and collaborative environment. Familiarity with ATS platforms (we use iCIMS but if you’re familiar with other applicant tracking systems that’s fine as well) and sourcing tools like LinkedIn Recruiter. Strong communication and collaboration skills. Fluency in English is a must. Be able to work from the office. Preferred: Prior experience in clinical research, biotechnology, healthcare technology, technology or a CRO (contract research organization) setting. CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes

Artemis Education and Research Foundation Applications are invited on contractual basis for the post of Project Research Scientist-I in an ICMR funded Project (IIRP-2023-6761/F1) under the project Understanding the molecular mechanisms predisposing colistin heteroresistance in Klebsiella pneumoniae clinical isolates Name of Post: Project Research Scientist-I No. of position : 1 Essential Qualification: First Class Post Graduate Degree, including the integrated PG degree in Bioinformatics, with three Years Experience or PhD. OR Second Class Post Graduate Degree, including the integrated PG degree in Bioinformatics, with PhD and three years Experience Desirable Qualification: Experience in bioinformatics data analysis (identification of mutations, resistance genes, sequence typing etc) Salary : Rs. 67,200/- Last date for submission of application: 31st July 2025

Description Senior Medical Writer (CSR, IB , Protocol) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects Qualifications Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred 5 years of relevant experience in science, technical, or medical writing Experience working in the biopharmaceutical, device, or contract research organization industry required Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus Leading the clear and accurate completion of medical writing deliverables Managing medical writing activities associated with individual studies Coordinating these activities within and across departments Completing a variety of documents, adhering to established regulatory standards Coordinating quality and editorial reviews Acting as peer reviewers for the internal team Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs Performing online clinical literature searches and complying with copyright requirements Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentoring and leading less experienced medical writers on complex projects Developing deep expertise on key topics in the industry and regulatory requirements Working within budget specifications for assigned projects

Site Name: GSK HQ, Belgium-Wavre, India - Karnataka - Bengaluru, Mississauga Milverton Drive, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence, Warsaw Posted Date: Jul 17 2025 VP, Global Clinical Study Delivery Accountable for the Clinical Study Delivery from phase I to IV of the overall GSK portfolio, the VP Global Clinical Study Delivery is critical to drive competitiveness & performance against the R&D progression targets. This role will effectively partner with numerous senior stakeholders to drive innovative approaches in trial delivery to enable GSK to remain competitive and lead the Pharma Industry in Study Delivery. An average of approximately 235 interventional and 70 non-interventional active Clinical Studies are under this roles accountability per year. The incumbent will lead a global team of 400 staff, based in US, Europe & UK plus a growing presence in India, Poland and Canada alongside key partners across the GSK global footprint. This role will be the line manager of a new Study Delivery LT – comprising predominantly a mix of Director and Senior Director level colleagues. This role will be pivotal in realising GSK's growth ambition by ensuring the successful delivery of its complex, multi-faceted, clinical programs, overseeing the strategic and operational forecasting and execution of clinical studies across all phases, ensuring timely, budget-conscious, and highest-quality delivery. The VP, Global Clinical Study Delivery will work closely with leaders across Development, R&D, Biostatistics, Clinical Operations, Regulatory, CPO, Commercial and external partners to drive robust scenario planning, optimise critical paths, and anticipate complex interdependencies that must be managed to execute Study plans flawlessly. This role will serve as a mediator and resolution pathway in the event of escalation, requiring elevated influencing and negotiation skills at a senior stakeholder level. The incumbent will also be accountable for developing and implementing a comprehensive clinical resourcing strategy, ensuring the team has the requisite talent and expertise to deliver the pipeline. By fostering a culture of excellence, collaboration, and continuous improvement, the VP, Global Clinical Study Delivery will ensure GSK's clinical delivery capabilities are best-in-class and aligned with the company's strategic objectives. This role will foster appropriate bridges across GCO (Global Clinical Operations) ensuring alignment with GSK's strategic portfolio priorities and driving performance to accelerate the delivery of our Medicines (including Viiv) and Vaccines to patients. Key Responsibilities: Develop and Lead a High-Performing Organisation : Build, lead and manage a global team of 400+ clinical study delivery professionals, mainly located in EU (BE, IT, PL), US, CA, IN, ensuring they are equipped with the necessary skills and resources to deliver clinical studies effectively and efficiently. Operational Excellence : Oversee the operational execution of clinical trials across all phases, ensuring they are delivered on time, within budget, and to the highest quality standards. Optimised Ways of Working : Embed and drive adherence to Study Team Operating Model (STOM) across Development functions. Resource Management : Develop and implement a comprehensive clinical resourcing strategy to ensure the team has the requisite talent and expertise to deliver the pipeline. Optimise resource allocation and manage budget forecasting and financial planning. Stakeholder Collaboration : Partner with senior stakeholders across R&D, Biostatistics, Clinical Operations, and external partners to drive robust scenario planning, optimise critical paths, and manage complex interdependencies of the studies execution. Performance Optimisation : Partner with other GCO (Global Clinical Operations) functions to establish and enhance industry-leading clinical delivery capabilities, tools, processes, and ways of working to ensure GSK R&D can effectively and productively deliver differentiated medicines and vaccines. Build bridges across GCO : As a key member of the GCO LT, this role will ensure appropriate bridges across GCO (Global Clinical Operations) ensuring alignment of study execution priorities with GSK's strategic portfolio priorities and driving performance. Continuous Improvement : Foster a culture of excellence, collaboration, and continuous improvement within the clinical study delivery team. Benchmark externally to ensure best-in-class practices and address gaps. Risk Management : Proactively identify and manage risks associated with clinical study delivery. Develop and implement strategies to mitigate risks and ensure the successful execution of clinical trials. Talent Development : Attract, develop, and retain an exceptional and diverse cadre of clinical study delivery experts. Ensure a commitment to inclusion and personal development, creating an environment where each team member can thrive. Why You? Basic Qualifications BSc degree in a scientific or business discipline as a minimum. Significant pharmaceutical R&D or related industry experience. Proven track record leading the delivery of multiple Assets/Trials and driving acceleration of a pipeline delivery. In depth experience of the drug/vaccine Clinical Operations processes including scenario planning, budget forecasting / management, risk identification / management, and greater understanding of the variability of assumptions supporting robust quality drug / vaccines development plans and the ability to drive an organisation to deliver to plan. A track record in leading large, multi-cultural organisations successfully, in where people are challenged, developed and talent management is driving performance. Preferred Qualifications: You will stand out if you also bring the following: Master’s Degree Experience in organisation-wide problem solving and high-quality strategic analysis. Experience working independently with the company executive team, and the ability to quickly build personal credibility and assimilate business issues/need. Strong influencing and negotiations skills in challenging, ambiguous and/or changing environments. Strong ability to collaborate, build bridges, with good verbal, written, presentation communications skills. Demonstrated skill operating in situations characterised by complexity, ambiguity and high levels of uncertainty. High level of energy, enthusiasm and commitment. High degree of creativity and innovation in developing new approaches, processes and methodologies. Ability to build credibility quickly across a diverse range of functional teams, seniority, and geography. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Summary The Director, NoCC Lead USMA – HYD Evidence Generation (EG) will lead the USMA Evidence Generation (EG) function at the NOCC Hyderabad site, with a direct reporting line to the USMA EG leadership team. The Director will establish, manage, and scale core capabilities across Real-World Evidence (RWE) analytics, economic modeling, clinical study operations (including IITs, RCs, and NIS), data management, and biostatistics. The role will ensure seamless day-to-day operations and delivery of high-quality, compliant outputs aligned with USMA strategic priorities. The Director will build and lead a high-performing team, implement effective governance frameworks, and act as the primary interface between the Hyderabad EG team and US-based stakeholders. The position requires deep subject matter expertise, strong operational leadership, and the ability to navigate a complex, global matrix environment. This is a high profile and high exposure role for both US and Hyderabad sites. About The Role Location – Hyderabad Major Responsibilities Lead and oversee execution of USMA clinical studies (IITs, RCs, NIS) from the Hyderabad site. Manage RWE analytics, economic modeling, biostatistics, and data management teams. Establish robust local processes, team structures, and performance management systems - including troubleshooting and performance improvement. Ensure timely, high-quality, and compliant delivery of evidence generation outputs. Maintain clear communication and alignment with USMA leadership and US-based functional heads. Very strong functional leader, with the ability to influence across senior leaders in Novartis. Develop and meet operational KPIs to contribute to overall USMA success. Proactively address delivery risks and execute mitigation plans. Ensure timely, high-quality, and compliant delivery of Evidence Generation services as defined with US Medical Affairs leadership. Manage performance including acquiring Novartis leader feedback to give specific associate insights on where performance is meeting standards or requires action to correct. Manage corrective actions or termination in accordance with company policy and in compliance with local regulations as necessary. Drive hiring, onboarding, training, and long-term capability building for the site. Manage poor performance, including termination of staff in accordance with company policy and regulatory compliance if necessary. Contribute to cross-site alignment across NOCC locations and harmonize ways of working. Represent Hyderabad EG operations in senior forums and contribute to strategic planning. Build Teams and foster a culture of collaboration, innovation, and continuous improvement. Develop and present (verbal and written) executive-level reports and dashboards for local Hyderabad and US leadership. This role will oversee approximately 10-45 direct reports in Hyderabad, with potential to grow and develop the team over time based on business needs. This role will report directly to the Head of Evidence Generation in the US. Minimum Requirements 8-10Years previous work in Multinational Pharmaceutical or CRO environments. Significant experience in leading end-to-end clinical study operations including IITs, RCs, and NIS studies. Proven track record in RWE analytics, data science, economic modeling, and biostatistics. Strong understanding of regulatory, quality, and compliance standards in EG. Strong business acumen and solution-orientation mindset including budget oversight, resource planning, and P&L management Excellent individual coaching and team development skills. Inspiring leader capable of fostering a sense of belonging. Ability to lead in environments with direct and indirect authority. Experience in remote relationships (on-shore/off-shore capability delivery). Experience managing complex programs and processes in a dynamic environment – scoping, defining deliverables, business case development and reporting at a senior level including the ability to communicate effectively and to have a persuasive and credible presentation styl Demonstrated ability to lead cross-functional teams in matrixed, multicultural settings. Education Advanced degree in Life Sciences, Pharmacy, Health Economics, Statistics, Public Health, or related field (e.g., PhD, MPH, MSc, PharmD). Strongly Preferred Requirements Executive presence and effective stakeholder engagement across senior levels. Strong communication and analytical skills; fluent in English (written and spoken). Exceptional problem-solving skills and ability to align work to goals to produce effective outcomes US work or equivalent experiences Strong comprehension of US language, terminology, and ability to interpret information High emotional intelligence and proven team-building capabilities. Financial acumen, including budget oversight and resource planning. Deep familiarity with EG systems, governance, and data platforms. Ability and Willingness to travel internationally up to 30% Willingness to work and be available during US business hours (up to 8:00 p.m. IST or 10:30 a.m. EST), schedule coordination in advance to ensure US Holiday coverage, and on call for critical matters, based on business needs. Strong understanding of the US Marketplace, emerging US Policies, and US Healthcare Landscape. Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products that cater to the needs of underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products cover various therapeutic areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, benefiting millions of patients worldwide. For more information about Azurity, please visit www.azurity.com. Azurity Pharmaceuticals is committed to fostering an inclusive workplace and is proud to be an Equal Opportunity Employer. The company attributes its success to its talented and dedicated team that prioritizes improving patients" lives by incorporating the best science and commitment to quality in all aspects of its work. Azurity seeks individuals who are highly motivated, possess integrity, dedication, and a creative spirit to excel within the organization. As a part of the Clinical Development team at Azurity, the Manager, Clinical Development plays a vital role in supporting early development activities across multiple therapeutic areas. Reporting to the Director, Clinical Development, the candidate will collaborate with stakeholders and team members to ensure scientific excellence, build effective relationships across Research & Development, and optimize the design and analysis of clinical investigations. **Principle Responsibilities:** - Design studies with a focus on technical, regulatory, and formulation aspects. - Collaborate with program managers and study teams to develop study plans aligned with the overall development plan and key milestones. - Ensure compliance with GCP, local and target regulatory guidelines, study protocols, and identify and address areas of concern. - Oversee study operations, including initiation, monitoring, and closeout, sample shipment, and communication with CROs, involving travel to CRO locations and study sites. - Independently perform non-compartmental PK analysis, PK modeling, and IVIVC communication of trial status and data to cross-functional teams. - Manage data repository, TMF, and critical study documents, proposing alternative strategies to optimize time, cost, and resources. - Contribute to the development, review, and approval of clinical study documents, such as ICF, IB, CRFs, study reports, and regulatory documents. **Qualifications And Education Requirements:** - Master's, Pharm.D, or PhD degree in clinical research, pharmacology, or equivalent field. - Minimum 6 years of pharmaceutical industry experience, with 4-5 years of experience in Phase 1 or 2 clinical development. - Sound understanding of US and ex-US regulatory clinical requirements, drug development continuum, and knowledge of regulatory approval processes. - Familiarity with ICH guidelines, GCP, biostatistics, and pharmacokinetics. - Strong organizational, interpersonal, and communication skills with the ability to work collaboratively in a cross-functional team. - Excellent analytical, problem-solving, and communication skills. By applying for this role, you confirm your ability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have concerns or disabilities that may affect your performance, please inform HR in advance.,

Summary Position Summary Job Description - Strategy & Transactions – Strategy (Consultant) At Deloitte Strategy & Transactions (S&T), we don’t just advise — we architect the future. Our team is uniquely positioned at the intersection of strategy and execution, empowering clients to tackle their most pressing challenges and unlock transformative growth. We work with C-suite executives, Boards, and business leaders to answer the questions that matter most — from navigating complex M&A and driving digital transformation, to reshaping operating models and unlocking new market opportunities. We are trusted advisors during our clients' most critical, high-stakes moments. But we don’t stop at client impact — we are equally passionate about investing in our people. At S&T, you’ll be part of a dynamic team culture that accelerates leadership development, fosters curiosity, and delivers hands-on experience at the forefront of strategy and transactions. We design differentiated career paths that empower our talent to thrive. Our capabilities span the full lifecycle of transformation — from Enterprise and Growth Strategy to Enterprise Technology and Transformation Strategy , end-to-end M&A, valuation and modeling, and performance improvement & restructuring, to infrastructure & real estate advisory and sustainability-driven innovation. If you’re looking to work where bold thinking meets real-world impact — and where your growth matters as much as your clients’ — Strategy & Transactions is your next move. The team Our Strategy practice brings together several key capabilities that will allow us to architect integrated programs that transform our clients’ businesses, including Corporate & Business Unit Strategy, Technology Strategy & Insights, Enterprise Model Design, Enterprise Cloud Strategy and Business Transformation. Strategy professionals will serve as trusted advisors to our clients, working with them to make clear data-driven choices about where to play and how to win, in order to drive growth and enterprise value. Work you will do: Deloitte’s ‘Strategy’ offering helps companies address the entire range of top management challenges including pursuing new growth opportunities, developing go-to-market strategies, channel strategies, and pricing strategies. Identify strategies for growth and value creation Develop the appropriate business models, technology operating models, and capabilities to support their strategic vision Maximize the ROI on technology investments and leverage technology trends to architect future technology strategies Required Experience And Skills Enterprise Technology and Transformation Strategy – Life Sciences and Health Care (LSHC) LSHC Industry Experience Consulting experience for clients in the Life Sciences and Healthcare industry Hands-on exposure of working for / with leading companies in the Life Sciences (Pharmaceutical / Biotech), US Provider and/or US Payor/Health Plan/PBM industries (minimum 1+ year of experience) Awareness of industry trends, challenges, technology adoption levels and solution landscape in at least one of the sub-sectors in Life Sciences and Healthcare Enterprise Technology and Transformation Strategy Ability to articulate leading business issues and trends including the associated technology implications Demonstrate application of business acumen while leveraging information technology Experience of being a Technology Product Owner and responsible for delivering product model and communicating the product needs with business partners Strong understanding of front to back architecture principles, technology stack, infrastructure with exposure to new age tools One life cycle project execution experience in recommending and/or implementing IT strategy and solutions for improving business outcomes Exposure to working in non-India Geographies (preferably the US) and / or interacting with Global stakeholders Candidates with project experience in one or more of the following areas is good to have: IT Strategy & Alignment – Delivering IT Strategy, driven both from a top-down analysis starting with an articulated business strategy and a bottom-up technology capability analysis; Experience working on cost reduction techniques, portfolio modernization and delivery roadmap creation for LSHC players Technology Operating Model Design - Assessment of current state operating model -its underlying processes, ability to identify pain points and process gaps; design of target state operating model and associated roadmap Enterprise Architecture – Experience of Enterprise Architecture capabilities such as Blueprinting, solution architecture, architecture assessment, planning and cost estimation. Knowledge of any of the major Enterprise Architecture Frameworks (preferred) E.g. TOGAF , FEA(F), and DoDAF. Experience with CTMS, LIMS, Compliance, GXP, MES, Argus, Oracle systems preferred IT Outsourcing: Experience working on IT Outsourcing model, CROs, BPOs etc. vendor analysis and benchmarking, contract analysis and understanding of how IT resources create shareholder (business) value Enterprise Data Management & Governance : Strong understanding of data management process across the data lifecycle (MDM, ingestion, storage, transformation) with experience in evaluating the client's data landscape and architecture to identify opportunities for improvement. Assessing current data governance practices and maturity within client organizations, having the ability to define and implement data governance strategies and frameworks for organizations. Additionally, having regulatory experience such as those of US FDA, EMEA, and DCGI are desirable AI/ML – Strong understanding of AI/ML concepts and frameworks, ability to design solutions around automation including advanced AI / ML solutions in areas of deep learning, machine learning, NLP, Simulation etc.; knowledge of AI/ML implementation use cases for players in LSHC industry (e.g., impact of Gen AI on healthcare value chain, specifically in R&D, manufacturing and commercialization of the drug) Cloud Strategy – Understand the impact of cloud computing in business and technology decisions, ability to identify and articulate the business and technology drivers of cloud computing, design of business cases for cloud. Certifications such as AWS, GCP, Azure will be a plus. Experience with workload assessment, business cases development, operational assessment, roadmap creation, vendor selection DevOps / Agile – Strong understanding of Agile, DevOps, CI/CD, Site Reliability Engineering with hands on experience on tools such as Jenkins, Git and JIRA Core Consulting Skills Clear and concise communication - conduct client interviews, participate in workshops/trainings and present recommendations. Good client presence – interact and build relationships with clients and other team members Analytical thinking - ability to perform detailed, quantitative analysis and research (primary and secondary). Synthesize and present insights and recommendations from data. Logical structuring - structured approach to problem solving and ability to perform root cause analysis of client problems Deadline-oriented and quality focused - develop and own development of deliverables. Own and manage specific work-thread, develop plans for components of engagement, manage and mentor junior resources Collaboration - Be able to work both independently and as part of a team with professionals at all levels. Be able to prioritize tasks, manage change in scope, work on multiple assignments, and raise concerns/questions where appropriate Network - ability to chart one’s own career and build networks within the organization Qualifications Required: MBA, MS, M. Tech., or PHD from a premier school in India or abroad. Educational background in Biotech / Pharmaceutical / Biomedical / Biochemistry / Bioinformatics / Biostatistics preferred 1-3 years of relevant experience post MBA / MS / MTech 1-2 years with LSHC industry focus Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Professional development At Deloitte, professionals have the opportunity to work with some of the best and discover what works best for them. Here, we prioritize professional growth, offering diverse learning and networking opportunities to help accelerate careers and enhance leadership skills. Our state-of-the-art DU: The Leadership Center in India, located in Hyderabad, represents a tangible symbol of our commitment to the holistic growth and development of our people. Explore DU: The Leadership Center in India . Benefits To Help You Thrive At Deloitte, we know that great people make a great organization. Our comprehensive rewards program helps us deliver a distinctly Deloitte experience that helps that empowers our professionals to thrive mentally, physically, and financially—and live their purpose. To support our professionals and their loved ones, we offer a broad range of benefits. Eligibility requirements may be based on role, tenure, type of employment and/ or other criteria. Learn more about what working at Deloitte can mean for you. Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Requisition code: 306021

Summary Position Summary Job Description - Strategy & Transactions – Strategy (Consultant) At Deloitte Strategy & Transactions (S&T), we don’t just advise — we architect the future. Our team is uniquely positioned at the intersection of strategy and execution, empowering clients to tackle their most pressing challenges and unlock transformative growth. We work with C-suite executives, Boards, and business leaders to answer the questions that matter most — from navigating complex M&A and driving digital transformation, to reshaping operating models and unlocking new market opportunities. We are trusted advisors during our clients' most critical, high-stakes moments. But we don’t stop at client impact — we are equally passionate about investing in our people. At S&T, you’ll be part of a dynamic team culture that accelerates leadership development, fosters curiosity, and delivers hands-on experience at the forefront of strategy and transactions. We design differentiated career paths that empower our talent to thrive. Our capabilities span the full lifecycle of transformation — from Enterprise and Growth Strategy to Enterprise Technology and Transformation Strategy , end-to-end M&A, valuation and modeling, and performance improvement & restructuring, to infrastructure & real estate advisory and sustainability-driven innovation. If you’re looking to work where bold thinking meets real-world impact — and where your growth matters as much as your clients’ — Strategy & Transactions is your next move. The team Our Strategy practice brings together several key capabilities that will allow us to architect integrated programs that transform our clients’ businesses, including Corporate & Business Unit Strategy, Technology Strategy & Insights, Enterprise Model Design, Enterprise Cloud Strategy and Business Transformation. Strategy professionals will serve as trusted advisors to our clients, working with them to make clear data-driven choices about where to play and how to win, in order to drive growth and enterprise value. Work you will do: Deloitte’s ‘Strategy’ offering helps companies address the entire range of top management challenges including pursuing new growth opportunities, developing go-to-market strategies, channel strategies, and pricing strategies. Identify strategies for growth and value creation Develop the appropriate business models, technology operating models, and capabilities to support their strategic vision Maximize the ROI on technology investments and leverage technology trends to architect future technology strategies Required Experience And Skills Enterprise Technology and Transformation Strategy – Life Sciences and Health Care (LSHC) LSHC Industry Experience Consulting experience for clients in the Life Sciences and Healthcare industry Hands-on exposure of working for / with leading companies in the Life Sciences (Pharmaceutical / Biotech), US Provider and/or US Payor/Health Plan/PBM industries (minimum 1+ year of experience) Awareness of industry trends, challenges, technology adoption levels and solution landscape in at least one of the sub-sectors in Life Sciences and Healthcare Enterprise Technology and Transformation Strategy Ability to articulate leading business issues and trends including the associated technology implications Demonstrate application of business acumen while leveraging information technology Experience of being a Technology Product Owner and responsible for delivering product model and communicating the product needs with business partners Strong understanding of front to back architecture principles, technology stack, infrastructure with exposure to new age tools One life cycle project execution experience in recommending and/or implementing IT strategy and solutions for improving business outcomes Exposure to working in non-India Geographies (preferably the US) and / or interacting with Global stakeholders Candidates with project experience in one or more of the following areas is good to have: IT Strategy & Alignment – Delivering IT Strategy, driven both from a top-down analysis starting with an articulated business strategy and a bottom-up technology capability analysis; Experience working on cost reduction techniques, portfolio modernization and delivery roadmap creation for LSHC players Technology Operating Model Design - Assessment of current state operating model -its underlying processes, ability to identify pain points and process gaps; design of target state operating model and associated roadmap Enterprise Architecture – Experience of Enterprise Architecture capabilities such as Blueprinting, solution architecture, architecture assessment, planning and cost estimation. Knowledge of any of the major Enterprise Architecture Frameworks (preferred) E.g. TOGAF , FEA(F), and DoDAF. Experience with CTMS, LIMS, Compliance, GXP, MES, Argus, Oracle systems preferred IT Outsourcing: Experience working on IT Outsourcing model, CROs, BPOs etc. vendor analysis and benchmarking, contract analysis and understanding of how IT resources create shareholder (business) value Enterprise Data Management & Governance : Strong understanding of data management process across the data lifecycle (MDM, ingestion, storage, transformation) with experience in evaluating the client's data landscape and architecture to identify opportunities for improvement. Assessing current data governance practices and maturity within client organizations, having the ability to define and implement data governance strategies and frameworks for organizations. Additionally, having regulatory experience such as those of US FDA, EMEA, and DCGI are desirable AI/ML – Strong understanding of AI/ML concepts and frameworks, ability to design solutions around automation including advanced AI / ML solutions in areas of deep learning, machine learning, NLP, Simulation etc.; knowledge of AI/ML implementation use cases for players in LSHC industry (e.g., impact of Gen AI on healthcare value chain, specifically in R&D, manufacturing and commercialization of the drug) Cloud Strategy – Understand the impact of cloud computing in business and technology decisions, ability to identify and articulate the business and technology drivers of cloud computing, design of business cases for cloud. Certifications such as AWS, GCP, Azure will be a plus. Experience with workload assessment, business cases development, operational assessment, roadmap creation, vendor selection DevOps / Agile – Strong understanding of Agile, DevOps, CI/CD, Site Reliability Engineering with hands on experience on tools such as Jenkins, Git and JIRA Core Consulting Skills Clear and concise communication - conduct client interviews, participate in workshops/trainings and present recommendations. Good client presence – interact and build relationships with clients and other team members Analytical thinking - ability to perform detailed, quantitative analysis and research (primary and secondary). Synthesize and present insights and recommendations from data. Logical structuring - structured approach to problem solving and ability to perform root cause analysis of client problems Deadline-oriented and quality focused - develop and own development of deliverables. Own and manage specific work-thread, develop plans for components of engagement, manage and mentor junior resources Collaboration - Be able to work both independently and as part of a team with professionals at all levels. Be able to prioritize tasks, manage change in scope, work on multiple assignments, and raise concerns/questions where appropriate Network - ability to chart one’s own career and build networks within the organization Qualifications Required: MBA, MS, M. Tech., or PHD from a premier school in India or abroad. Educational background in Biotech / Pharmaceutical / Biomedical / Biochemistry / Bioinformatics / Biostatistics preferred 1-3 years of relevant experience post MBA / MS / MTech 1-2 years with LSHC industry focus Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Professional development At Deloitte, professionals have the opportunity to work with some of the best and discover what works best for them. Here, we prioritize professional growth, offering diverse learning and networking opportunities to help accelerate careers and enhance leadership skills. Our state-of-the-art DU: The Leadership Center in India, located in Hyderabad, represents a tangible symbol of our commitment to the holistic growth and development of our people. Explore DU: The Leadership Center in India . Benefits To Help You Thrive At Deloitte, we know that great people make a great organization. Our comprehensive rewards program helps us deliver a distinctly Deloitte experience that helps that empowers our professionals to thrive mentally, physically, and financially—and live their purpose. To support our professionals and their loved ones, we offer a broad range of benefits. Eligibility requirements may be based on role, tenure, type of employment and/ or other criteria. Learn more about what working at Deloitte can mean for you. Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Requisition code: 306021

Title of project-: Regional Resource Hub at NIRRH for Health Technology Assessment in India funded by Department of Health Research, Ministry of Health and Family Welfare, Government of India. Name of the Post-: Senior Health Economist (Medical / Non-Medical) No. of vacancy -: One Consolidated Salary -: Rs.1,56,100/- (Rs.1,23,000/- plus 27% HRA) Essential Qualification -: MD/ MS / DNB or Ph.D. in any of the subjects like Biochemistry, Health Economics, Public Health, Biosciences, Microbiology, Pharmacology, Biotechnology and Biostatistics AND/OR Equivalent Degree with 3 to 6 Years Experience after MD / MS / Ph.D. in Health Economics or Systematic Review. Desirable / Job Description -: 8-12 years in R&D and academic Institutions / Scientific Organizations in the relevant subject including 3 years in a managerial position with experience in Economic Evaluation with atleast 10 Publications on Health Economics related studies. Age Limit -: 52 Years Duration -: One Year (further continuation based on performance) Place of Posting -: ICMR-NIRRCH, J.M. Street, Parel, Mumbai 400012, Maharashtra. Interested candidate share your updated CV on this Mail ID :- anushka.y@esolglobal.com

Premier Research is looking for a Director, Biostatistical Programming to join our Biostatistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. What You'll Be Doing The Director, Biostatistical Programming serves as core team member and leader for larger projects. This position is responsible for Biostatistical Programming operations, directing project assignments, and the overall activities of project team personnel. The Director also reviews departmental deliverables for accuracy, completeness, and compliance with project specifications to ensure quality deliverables to Sponsors. The Director is responsible for both management and technical aspects of development projects. As a technical expert, this individual provides strategic guidance to development projects. When functioning in a supervisory role, the Director provides coaching guidance to more junior staff and line management to the team, while overseeing the technical evolution of the departmental work product. Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop and maintain the team structure Provides support for the maintenance and management of the biostatistics macro library Prepares specifications for CDISC and other analysis data sets Performs QC (source code review, double-programming and log review) of SAS programs Participates in and contributes to the training and development of new Biostatistical Programmers Lead efforts in the development, maintenance and adherence to departmental SOPs and guidelines Keeps up on CDISC and other industry standards and ensures dept is kept up to date Integrates operational practices within the department across all offices/regions Develops SAS programs to generate tables and listings without shells Develops SAS programs to generate listings, tables and graphs as outlined by TLF shells Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Develops listing shells for SAP Develops and validates standard macros and template programs using SAS and other software tools Develops and validates general SAS macros Develops and implements non-SAS software Creates define packages for CDISC datasets Contributes to the tracking of project revenue and backlog Contributes to the tracking of hours worked on projects and forecasts hours to complete Contributes to the definition of standards and harmonized procedures across offices/regions Contributes to efforts in Biostatistics project costing estimates and change order process Capability and willingness to coach and mentor others Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team What We Are Searching For BS or equivalent from accredited college or university, in statistics, IT, mathematics or equivalent experience with programming in a scientific field. Equivalent combination of education, training and experience will be considered. 15+ years’ experience in SAS programming within the area of clinical trials. 7+ years’ experience as supervisor/manager Demonstrated excellent knowledge of data processing, database design and organization in clinical data environment. Demonstrated excellent knowledge of basic clinical trial design and analysis principles. Excellent working knowledge of CDISC standards and application of these standards to projects. Excellent working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics. Strong computer skills, with evidence of advanced SAS programming skills. Ability to support Biostatisticians with advanced statistics with little or no supervision on standalone projects. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms. Detail oriented, well organized. Excellent English Communication skills (verbal, written & interpersonal).

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*).The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings. **This position is for the Chennai Location and not home-based** In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites). Plan and project the resources required including management of tasks, timelines, risk and quality. Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition. Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements. Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements. Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs). Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed. Create training materials for EDC users and provide project-specific training as required. Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock). Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data. Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance. Organize and lead Quality Review activities during study. Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA). Manage the database maintenance, lock and close-out processes and procedure. Participate in conference calls and/or meetings with vendors and sponsors. Recognize and solve potential problems and evaluate effectiveness. Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date. Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned. Help to align data management and clinical programming best practices, standards and conventions within the company. Provide leadership, expertise and support to other department members. Propose and support initiatives for improving efficiency. Actively support to staff learning & development within the company. Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions . Represent the company at professional meetings, webinars or seminars. Train and mentor data management staff, support in development of new training material and provide training to relevant staff. Participate in the interview process for new recruits. Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes. Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients. Contribute to and take part in client evaluations and visits. Support in preparation of new proposals and budgets for Data Management services. Requirements To be successful you should possess: Life science, healthcare degree and/or combination of education and experience. Minimum 5 years of relevant work experience asa Clinical Data Manager. Minimum 5 years of experience in drug development and/or clinical research. Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements. Good understanding of Medical Terminology. Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA. Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock). Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation. Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models. Experience in developing data management standards. Strong written and verbal communication skills including a good command of the English language. Representative, outgoing and client-focused. Ability to work in a fast-paced challenging environment of a growing company. Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Administrative excellence. Attention to detail, strong technical, analytical and problem-solving skills. Strong project management skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations. Ability to simplify complex issues into understandable concepts. Excellent organizational, negotiating and motivational skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/office-based* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for Clinical Data Manager III (CDM III) to join our A-team. As CDM III at Allucent, you will manage and coordinate DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. PLEASE NOTE: This is not a remote position and we are looking for a candidate who can work from the office (Chennai Location). In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites) Plan and project the resources required including management of tasks, timelines, risk and quality Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs) Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks Create training materials for EDC users and provide project-specific training as required Review and validate clinical data to ensure consistency, accuracy, integrity and completeness Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock) Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance Support and conduct Quality Review checks during study. As lead DM, may organize and lead Quality Review activities Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA) Manage the database maintenance, lock and close-out processes and procedure Participate in conference calls and/or meetings with vendors and sponsors Recognize and solve potential problems and evaluate effectiveness Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned Help to align data management and clinical programming best practices, standards and conventions within the company Propose and support initiatives for improving efficiency. Requirements To be successful you will possess: Minimum Educational Requirement: Preferably Life science graduate or equivalent qualification 6+ years' experience in clinical data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries Proven knowledge of clinical data management processes and clinical database systems, including Electronic Data Capture applications. Good communication skills written and verbal. Effective working knowledge of Microsoft Office Suite including Word and Excel. Demonstrated proactiveness, problem-solving, analytical, organizational and time management skills. Demonstrated flexibility and ability to work well in a fast-paced growing organization. Demonstrated ability to work in a global team environment. Demonstrates a basic understanding of Clinical Trials and the flow of data. Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and POI SOPs. Comprehension of study documentation standards including Trial Master File organization and archival processes. Familiarization of data standards, preferably CDISC STDM. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*).The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings. **This position is for the Bengaluru Location and not home-based** In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites). Plan and project the resources required including management of tasks, timelines, risk and quality. Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition. Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements. Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements. Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs). Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed. Create training materials for EDC users and provide project-specific training as required. Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock). Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data. Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance. Organize and lead Quality Review activities during study. Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA). Manage the database maintenance, lock and close-out processes and procedure. Participate in conference calls and/or meetings with vendors and sponsors. Recognize and solve potential problems and evaluate effectiveness. Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date. Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned. Help to align data management and clinical programming best practices, standards and conventions within the company. Provide leadership, expertise and support to other department members. Propose and support initiatives for improving efficiency. Actively support to staff learning & development within the company. Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions . Represent the company at professional meetings, webinars or seminars. Train and mentor data management staff, support in development of new training material and provide training to relevant staff. Participate in the interview process for new recruits. Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes. Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients. Contribute to and take part in client evaluations and visits. Support in preparation of new proposals and budgets for Data Management services. Requirements To be successful you should possess: Life science, healthcare degree and/or combination of education and experience. Minimum 5 years of relevant work experience asa Clinical Data Manager. Minimum 5 years of experience in drug development and/or clinical research. Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements. Good understanding of Medical Terminology. Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA. Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock). Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation. Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models. Experience in developing data management standards. Strong written and verbal communication skills including a good command of the English language. Representative, outgoing and client-focused. Ability to work in a fast-paced challenging environment of a growing company. Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Administrative excellence. Attention to detail, strong technical, analytical and problem-solving skills. Strong project management skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations. Ability to simplify complex issues into understandable concepts. Excellent organizational, negotiating and motivational skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Principal Responsibilities: Designs and develops statistical programs in support of clinical research analysis and reporting activities. Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities. Maintains statistical programming documentation as appropriate. Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables. Performs activities in compliance with departmental processes and procedures. Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals. Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships Reports into people manager position within the functional area. Accountable to the Programming Lead for assigned programming activities Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, Clinical – Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications - External Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field. In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred. Working knowledge of processes and concepts relevant to Statistical Programming. Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated written and verbal communication skills. Experience working in a team environment.

Job Description Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. Qualifications For Essential Functions Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

Company Name: Clinvigilant Research Pvt. Ltd. (A company of GSC Group) . Job Title: Clinical Data Manager Job Location: Ahmedabad- Onsite No. of Position :01 Experience : 03 to 06 Years. A Clinical Data Manager (CDM) plays a key role in managing and overseeing the data collected during clinical trials, ensuring its accuracy, integrity, and compliance with regulations. Here's a typical Job Description (JD) for a Clinical Data Manager Job Summary: The Clinical Data Manager oversees the collection, management, and quality control of clinical trial data. They will work closely with clinical research teams, statisticians, and regulatory authorities to ensure that data is accurately recorded, processed, and analyzed for clinical trials. The role involves ensuring that data is compliant with Good Clinical Practice (GCP) guidelines and relevant regulatory standards. Key Responsibilities: Data Management Plan (DMP): Develop, implement, and maintain the Data Management Plan for clinical trials. Ensure that the DMP aligns with study protocols, regulatory requirements, and internal standards. Database Design & Development: Collaborate with clinical and statistical teams to design and build electronic data capture (EDC) systems and clinical databases. Perform user acceptance testing (UAT) to ensure that the systems are functioning properly. Data Collection & Verification: Oversee the collection and validation of clinical trial data, ensuring all data is accurate and complete. Ensure data consistency by reviewing the case report forms (CRFs) for completeness, accuracy, and compliance. Data Cleaning & Quality Control: Implement and manage data cleaning processes, including discrepancy management, query resolution, and follow-up on data errors. Coordinate with clinical sites and vendors to resolve data issues and discrepancies promptly. Reporting & Documentation: Prepare and maintain comprehensive documentation related to data management processes and outcomes. Ensure all clinical trial data is properly archived for future reference and regulatory compliance. Regulatory Compliance: Ensure compliance with GCP, ICH guidelines, FDA regulations, and other applicable regulatory bodies. Support regulatory submissions by providing high-quality data sets and related documentation. Collaboration & Communication: Collaborate with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and IT departments. Serve as the primary point of contact for data-related queries and provide data insights to stakeholders. Training & Mentoring: Train clinical data staff and ensure they are informed of current processes, systems, and regulatory requirements. Provide ongoing guidance and mentorship to junior data management staff. Vendor Management: Manage and coordinate relationships with third-party vendors, including EDC providers, CROs, and other partners. Ensure that external vendors adhere to the agreed-upon timelines and data quality standards. Required Qualifications: Education: Bachelor’s degree in Life Sciences, Computer Science, Statistics, or related field. A Master's degree or professional certifications (such as CDISC, GCP, or Clinical Data Management certifications) are advantageous. Experience: 3-5 years of experience in clinical data management or related field, with a strong understanding of clinical trial processes and data handling. Skills: Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle, or similar platforms). Strong understanding of clinical data management concepts, regulatory requirements, and industry standards. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills for effective cross-functional collaboration. Ability to work under pressure and meet tight deadlines. Preferred Qualifications: Experience working with complex clinical trials (multi-site, multi-region). Knowledge of regulatory submissions and reporting (e.g., FDA, EMA). Familiarity with statistical programming and data analysis tools (e.g., SASR). Job Types: Full-time, Permanent Pay: ₹30,000.00 - ₹50,000.00 per month Schedule: Monday to Friday Ability to commute/relocate: Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required) Application Question(s): how you rate yourself in english proficiency( beginner/ average/ professional)? Education: Bachelor's (Required) Experience: CDM: 3 years (Required) Location: Ahmedabad, Gujarat (Required) Expected Start Date: 03/01/2022

Sponsor-dedicated JOB DESCRIPTION Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. Responsibilities As a Principal Statistical Programmer, your responsibilities will include: Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros Participate in the development of CRFs, edit check specifications, and data validation plans Provide review and/or author data transfer specifications for external vendor data Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices Qualifications Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities Must be able to work independently Outstanding communication skills (written and verbal) and strong leadership skills Preferred Qualifications (nice To Have) Prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)

Description Sr Medical Writer (CSR, IB, Protocol) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects Qualifications Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred 5 years of relevant experience in science, technical, or medical writing Experience working in the biopharmaceutical, device, or contract research organization industry required Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus Leading the clear and accurate completion of medical writing deliverables Managing medical writing activities associated with individual studies Coordinating these activities within and across departments Completing a variety of documents, adhering to established regulatory standards Coordinating quality and editorial reviews Acting as peer reviewers for the internal team Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs Performing online clinical literature searches and complying with copyright requirements Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentoring and leading less experienced medical writers on complex projects Developing deep expertise on key topics in the industry and regulatory requirements Working within budget specifications for assigned projects

You will be responsible for providing statistical input to the design, analysis, reporting, and interpretation of clinical studies, as well as contributing to publications. Utilize SAS or other software to develop custom programming code for generating tables, data listings, graphs, and derived datasets as specified in the protocol or statistical analysis plan. Ensure that all outputs meet quality standards and project requirements. Perform validation programming and collaborate with other Programmers, Biostatisticians, and project team members to resolve any discrepancies or findings. Keep the project team informed of programming progress and any issues requiring their attention. Adhere to applicable SOPs and relevant regulatory guidelines. Manage scheduling and time constraints across multiple projects simultaneously. Set goals based on management priorities and adapt to timeline or priority changes by reorganizing daily workload. Prepare in advance for internal meetings, contribute ideas, and show respect for the opinions of others. Demonstrate willingness to collaborate with team members, assist with projects, and support initiatives as necessary to meet business needs. Negotiate and establish accurate time estimates for completing study activities with internal team members and statistical management. Ensure completion of project activities within the allotted timeframe. Assist in drafting regulatory submissions and stay updated with current literature and research new methodologies. Identify, develop, and implement novel statistical methodologies to support medicine development. Uphold scientific integrity and animal welfare in all activities. Interact with global statisticians and implement their recommendations locally. Create and maintain standard macros and applications to enhance department efficiency. Actively participate in process/quality improvement initiatives, standardization efforts, and other non-clinical activities. Contribute to mentoring other team members, develop training courses, present training materials, provide feedback, and guide new associates in the process. Engage in knowledge-sharing activities to foster a collaborative work environment.,

The Biostatistician is responsible for the statistical analysis and interpretation of clinical trial data, working closely with cross-functional teams to ensure accurate and meaningful results. This role involves developing Statistical Analysis Plans (SAPs)and contributing to the randomization process. They will provide expert consultation on statistical methodologies and collaborate with the Statistical Programming team to ensure the integrity of data analyses and outputs. Responsibilities Provide statistical expertise in the design and analysis of clinical trials. Develop and author SAPs for assigned projects. Review clinical trial protocols to ensure statistical soundness and provide feedback to study teams. Author the protocol statistical sections and generate SAPs and study randomization. Analyze clinical trial data using advanced statistical techniques and software. Collaborate closely with Statistical Programmers to review and validate data sets, tables, listings, and other statistical outputs. Review and sign-off on relevant study documents and data management and programming deliverables. Provide programming support to supplemental or exploratory analyses any other internal and external ad-hoc requests. Stay current with relevant regulatory guidelines and ensure compliance in all statistical deliverables. Represent the biostatistics function on project teams and in cross-functional meetings. Perform other duties as required and assigned. Accountabilities Demonstrate efficient and accurate completion of all responsibilities. Support overall delivery strategy and OKRs as directed by management. Education Qualifications: Master’s or PhD in Statistics, Biostatistics, or a related field is required. Bachelor’s degree with substantial working experience in biostatistics will be considered. Experience 2+ years of biostatistics experience, preferably in clinical trials. Proficiency in statistical software such as SAS, R, or Python required. Experience in the life sciences, regulatory environments, and knowledge of 21 CFR Part 11 and GxP is highly preferred. Skills Strong statistical knowledge, including experience with survival analysis, mixed models, and longitudinal data analysis. Excellent problem-solving abilities and attention to detail. Demonstrated ability to work independently and within cross-functional teams. Strong written and verbal communication skills, with the ability to clearly present statistical findings. Familiarity with regulatory requirements for clinical trial data. ₹10,00,000 - ₹20,00,000 a year