510 Biostatistics Jobs - Page 4

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. ProPharma is seeking an experienced Senior Medical Writer II to join our dynamic team in India. In this role, you will be responsible for authoring high-quality medical writing deliverables that demonstrate precision, clarity, and efficiency. As a key contributor, you will provide expert medical writing support to ProPharma’s global clients, ensuring that all documents meet the highest scientific and regulatory standards. This position offers the opportunity to collaborate with cross-functional teams, contribute to impactful healthcare solutions, and grow within a leading provider of regulatory, clinical, and medical information services worldwide. Essential Functions With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission‑level documents). Supervises, trains, and mentors less experienced medical writers, as necessary. Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates. Strives to complete medical writing deliverables on time and within budget. With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines. Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables. Coordinates QC reviews of documents and maintains audit trails of changes as applicable. Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency. If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output). Performs peer review of documents written by other medical writers, as required. Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings). Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing. Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership. Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team. Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team. Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). Necessary Skills & Requirements Bachelor’s degree or higher, in a medical or scientific discipline. Minimum of 6 years’ experience writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics within a CRO, pharmaceutical, or biotechnology environment. Proven expertise in authoring and editing a wide range of medical writing deliverables across clinical, safety, regulatory, and device/diagnostics documents. Strong knowledge of clinical research principles, phases, and therapeutic areas, with the ability to interpret and present complex clinical data. Advanced understanding of global regulatory guidelines, submission requirements, and processes (e.g., ICH E3/E6(R2), EU MDR/IVDR, FDA, EMA), with proficiency in applying SOPs, client standards, and templates. Exceptional project management, communication, and time-management skills, with high attention to detail and quality. Experience mentoring junior writers and building collaborative relationships with clients and cross-functional teams. Proactive, resourceful, and adaptable, with the ability to work independently while seeking support when needed. Requirements We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

We are seeking a Sr Biostatistician to join a leading biopharmaceutical solutions organization. The ideal candidate will provide statistical support throughout the clinical trial lifecycle, from protocol development to the Clinical Study Report (CSR). This role involves preparing Statistical Analysis Plans, coordinating project activities, and serving as a key biostatistics representative on project teams. Roles and Responsibilities Provide support across all assigned statistical tasks during the lifecycle of a clinical trial project, from protocol development to the Clinical Study Report (CSR). Prepare Statistical Analysis Plans (SAPs) , including the development of well-presented mock-up displays for tables, listings, and figures. Coordinate the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high-quality work. Provide independent review of project work produced by other biostatisticians in the department. Create or review programming specifications for analysis datasets, tables, listings, and figures. Review SAS annotated case report forms (CRFs) and other study documentation to ensure all data is captured to support the planned analysis. Conduct and participate in the verification and quality control of project deliverables. Serve as the biostatistics representative on project teams, managing scheduling, time constraints, and proactively communicating any difficulties. Monitor progress on study activities against milestones and ensure project timelines are met. Provide statistical programming support as needed. Support business development activities by contributing to proposals and budgets. Coach and mentor other Biostatistics staff. Follow applicable SOPs, WIs , and relevant regulatory guidelines ( ICH ). Maintain well-organized and up-to-date project documentation to ensure inspection readiness. Skills Required A graduate degree in biostatistics or a related discipline. Proven experience in clinical trials. Proficiency in programming . Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines , and programming techniques utilized in clinical research. Experience across all statistical tasks required to support clinical trials, from protocol to CSR. Excellent written and verbal communication skills. The ability to effectively communicate complex statistical concepts.

We are seeking a Sr Biostatistician to join a leading biopharmaceutical solutions organization. The ideal candidate will provide statistical support throughout the clinical trial lifecycle, from protocol development to the Clinical Study Report (CSR). This role involves preparing Statistical Analysis Plans, coordinating project activities, and serving as a key biostatistics representative on project teams. Roles and Responsibilities Provide support across all assigned statistical tasks during the lifecycle of a clinical trial project, from protocol development to the Clinical Study Report (CSR). Prepare Statistical Analysis Plans (SAPs) , including the development of well-presented mock-up displays for tables, listings, and figures. Coordinate the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high-quality work. Provide independent review of project work produced by other biostatisticians in the department. Create or review programming specifications for analysis datasets, tables, listings, and figures. Review SAS annotated case report forms (CRFs) and other study documentation to ensure all data is captured to support the planned analysis. Conduct and participate in the verification and quality control of project deliverables. Serve as the biostatistics representative on project teams, managing scheduling, time constraints, and proactively communicating any difficulties. Monitor progress on study activities against milestones and ensure project timelines are met. Provide statistical programming support as needed. Support business development activities by contributing to proposals and budgets. Coach and mentor other Biostatistics staff. Follow applicable SOPs, WIs , and relevant regulatory guidelines ( ICH ). Maintain well-organized and up-to-date project documentation to ensure inspection readiness. Skills Required A graduate degree in biostatistics or a related discipline. Proven experience in clinical trials. Proficiency in programming . Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines , and programming techniques utilized in clinical research. Experience across all statistical tasks required to support clinical trials, from protocol to CSR. Excellent written and verbal communication skills. The ability to effectively communicate complex statistical concepts.

We are seeking a Principal Biostatistician with a strong background in efficacy analysis to join our team. The ideal candidate will have extensive experience in creating and validating CDISC-compliant datasets , developing statistical analysis plans, and producing high-quality mock tables, listings, and figures. This role requires a detail-oriented professional with excellent communication skills who can manage multiple projects and collaborate effectively with cross-functional teams. Must-Have Skills Hands-on experience with efficacy analysis. Ability to manage multiple projects and meet tight deadlines. Excellent communication and collaboration skills. Good to Have Skills Proficiency in CDISC standards , particularly ADaM (Analysis Data Model) and SDTM (Study Data Tabulation Model) . Experience in creating and validating ADaM datasets to ensure they are analysis-ready and compliant with regulatory requirements. Hands-on experience with the creation of statistical analysis plans (SAPs) and mock TLFs (Tables, Listings, Figures) . Soft Skills Excellent communication skills for collaborating with cross-functional teams and presenting findings. Strong attention to detail and problem-solving abilities. Ability to manage multiple projects and meet deadlines.

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: Position Summary: The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures. As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers. The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality. In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams. In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects. Principal Responsibilities: Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests. Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes. Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations. As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads. Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives. May play the role of a Delivery Unit/Disease Area Expert. Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position. Clinical Programming: Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards. Responsible for implementation of data tabulation standards. Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring. Statistical Programming: Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program. Principal Relationships: The Principal Programming Lead reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities. Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources. External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education and Experience Requirements: Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD). Experience and Skills Required: Approx. 12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. E xperience in early development/clinical pharmacology studies (BA/BE, DDI, FE etc.) will be preferable. In-depth knowledge of programming practices (including tools and processes). Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11) Project, risk, and team management and an established track record leading teams to successful outcomes. Excellent planning and coordination of project delivery. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors. Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments. Experience managing the outsourcing or externalization of programming activities in the clinical trials setting (e.g., Working with CROs, academic institutions) preferred experience. Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g., working with CROs, academic institutions) is preferred. Expert CDISC Standards knowledge. Expert knowledge of relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required for a Clinical Programming role. Excellent written and verbal communications and influencing and negotiation skills. Advanced knowledge of programming and industry standard data structures, thorough understanding of end-to-end clinical trial process and relevant clinical research concepts. Other: Innovative thinking allows for optimal design and execution of programming development strategies. Development and implementation of a business change/innovative way of working.

Join Our Team We celebrate our diverse workforce as an equal opportunity employer. Our benefits package is both competitive and progressive. Our core values and culture respect and recognize greatness within, as well as reflect a high level of integrity and commitment to foster excellence in all we do. Join us as we continue to grow and achieve. Working with other talented and open-minded individuals in a fun and casual working environment is only the beginning. Qualifications: The ideal candidate must possess a Masters degree or higher in Statistics or Biostatistics. Intermediate or advanced experience using statistical software (SAS, SUDAAN, R) is required. Previous experience analyzing large datasets (NHANES, NVSS, Medicare, BRFSS) is highly preferred. Knowledge of CVD and CVD risk factor epidemiology is preferred. This is a great opportunity for someone looking to apply their statistical expertise in a dynamic and innovative environment. Job Duties: - Provide statistical analysis, interpretations, and revisions to heart disease and Stroke prevention materials including materials for Million Hearts, Interactive Atlas, and Healthy People 2030. - Provide methods, analyses, and interpretation for at least two publications per year in peer-reviewed journals (or CDC MMWR) in support of Division priorities utilizing data sets including NHANES, CMS, BRFSS, NVSS, Medicare, Market scan, etc. - Provide ad-hoc statistical analysis in support of heart disease and stroke prevention activities to division scientists. - Work with division scientists performing data analysis on requested projects including developing the methodology and creating data tables to answer research questions as presented by the scientist.,

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 Location - Hyderabad and Mumbai EDUCATION AND EXPERIENCE REQUIRED Master's degree in Statistics or equivalent combination of Education and Experience (e.g. a bachelor’s degree and at least 5 years of industry experience as a biostatistician) required A minimum of 5 years of experience as a statistician is required for the Senior Statistician position. Proficient in SAS and similar clinical data analysis software

Description Senior Medical Writer (Project Mgt exp) 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 Minimum5 years of experienceinProject Management. Must possessexcellent communication skills and should beproficient inMicrosoft Office. Should have prior experience inteam handling. Mentors and leads less experienced medical writers on complex projects, as necessary. Acts as lead for assigned writing projects. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc., and serves as a medical writer within and across departments with minimal supervision. Ability to create process maps from provided technical material or from client inputs. Hands on experience of using MS Visio or similar tools. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. 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 providing review comments on draft and final documents. Adheres to established regulatory standards 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. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing. Maintains awareness 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%). Qualification Requirements 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. 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

Business Analyst JD. Responsibilities: Should be responsible and have a good attitude. Must have good written and communication skills in English and Malayalam. Desire to work in a fast-paced, entrepreneurial environment. Should be a fast learner and ready to work on any modules. As a Business System Analyst, you will analyze user needs and data to generate concepts, create prototypes, and iteratively improve solutions. Develop mock-ups and user requirements that IT and technical teams can use to build or enhance solutions. Collaborate with cross-functional teams to gather required data, interpret analysis insights, and explore potential solutions. Document, translate, and communicate findings effectively while advocating for key recommendations. Produce relevant deliverables. Collaborate with client engineering teams to conceptualize, develop, and deploy software solutions by translating business requirements into functional systems. Team up with agile squads, product managers and technical experts to craft business rationales and build proof-of-concept prototypes. Incorporates feedback on prototypes and iterates continuously to improve user experience and customer engagement. Keep abreast of healthcare IT developments encompassing standards, technologies, and workflow methodologies. Helps analyze, organize, and enhance clinical systems and processes to optimize their effectiveness in patient care delivery. Experience in Agile / Scrum methodology. Be a part in presales activities (technical proposal, RFP, POC, estimation and SLA preparation), recruitment. EXPERIENCE REQUIRED: 3 Year - 6 Years Qualification: B.Tech/ B.E/ MCA/ MHA or equivalent (FULL TIME SKILLS REQUIRED: Healthcare Application knowledge is preferred. Understanding of Clinical Data standards. Hands-on design experience with clinical research systems including Clinical Data Management Systems (CDMS), Electronic Health Records (EHR), and Electronic Medical Records (EMR) . Bridged clinical research needs with technical capabilities by working closely with biostatistics, regulatory, and IT teams to deliver fit-for-purpose solutions. Experience delivering advanced analytics/machine learning/AI solutions. System Requirements Gathering, Data analysis, Data Engineering and Writing experience (e.g. low fidelity mockups, user stories, storyboards, process flows) Strong analytical skills, willing to learn and apply leading-edge technologies. Hands on experience working in DevOps. Good at Word, Excel and PowerPoint. Good to have knowledge SQL and ANYONE programing language Job Type: Permanent Pay: Up to ₹1,000,000.00 per year Benefits: Provident Fund Application Question(s): How many years exposure in healthcare domain? Experience: healthcare industry: 1 year (Preferred) Business analysis: 4 years (Preferred) Work Location: In person

The Postdoctoral Fellow applicant will work in conjunction with the Principal Investigator to lead the Sex-Based Precision Medicine Research Core (SPMRC). The SPMRC will promote and support sex- and gender-based precision medicine (SPM) research at the Tulane Center of Biomedical Research Excellence in Sex-Based Precision Medicine (COBRE in SPM), assist Research Project Leaders (RPLs) and Pilot Project Leaders (PPLs) in obtaining independent research funding, and serve the broader scientific community by performing high-impact, sex-based biology and precision medicine (SPM) research. The study of sex and gender differences is a discipline in itself, with its own concepts and methods that apply across cells and tissues as well as clinical and population health. This critical aspect of SPM requires the use and knowledge of quantitative methods including biostatistics, epidemiology, and bioinformatics to design and analyze studies to assess the interactions of sex and gender with race, age, and social determinants of health (e.g., occupational hazards, lifestyle, social stresses, access to healthcare).

As a Lecturer in the Department of Biostatistics at C.B.C.I Society for Medical Education (St. Johns Medical College & Hospital), you will play a crucial role in various academic activities. Your primary responsibility will be to offer statistical guidance and support to both postgraduate students and faculty members, particularly in their research and thesis work. It is essential for you to actively participate in departmental and institutional activities to contribute effectively to the academic environment. Your key responsibilities will include: - Engaging in teaching activities for postgraduate and undergraduate programs as assigned. - Participating in curriculum development and academic planning to enhance the quality of education. - Contributing to departmental seminars, workshops, and training sessions to foster a collaborative learning environment. Moreover, you will be expected to: - Provide comprehensive statistical support for student theses by offering guidance on study design, data analysis, and interpretation. - Assisting faculty and researchers in designing, analyzing, and interpreting epidemiological and clinical studies to ensure the validity and reliability of research findings. - Contribute to writing scientific manuscripts, technical reports, and grant applications to disseminate research outcomes effectively. Ideally, you should hold an M.Sc. in Biostatistics, Health Statistics, Medical Statistics, or Statistics with at least one year of relevant experience. A Ph.D. in Biostatistics or Statistics would be desirable. The age limit for this position is 45 years. If you are passionate about contributing to the field of Biostatistics in a renowned institution like St. John's National Academy of Health Sciences, please email your CV to sjmch.recruitment@stjohns.in to apply for this exciting opportunity.,

About The Job Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities The Principal Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans (SAP), programming specifications for analysis datasets and provide QC done data packages including tables, figures, and listings for use in publications (i.e., abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable; The Principal Biostatistician will ensure SOPs are followed, communications, timelines and quality metrics are met.; Collaboration of Local biostatistics and programming teams, Global Medical Affairs biostatisticians and / or programmers, and Global Medical Affairs Scientific Communications personnel . People Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. Support Sanofi Business Operations Leadership Team in understanding of stakeholders needs & expectations and provide end to end solutions for TAs/indications. Coach/mentor new team members to support efficient and quick onboarding. Support graduate hiring program as needed. Performance / Process Conduct appropriate post-hoc or ad-hoc statistical analyses of clinical trial data and / or registry (i.e., Observational) data. Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. Produce well documented data packages that include tables, listings, and figures. Work closely with the Team Lead Biostatistician and/or Team Lead Programmer to develop and implement project QC plans, timelines and KPIs. Learn, implement, and share through lecture series at least one indication of disease and product (Immunology, Multiple Sclerosis and Neurology, Rare Diseases, Rare Blood Disorders and Oncology) expertise. Review appropriate biomedical and clinical research literature related to assigned project(s). Active participation and Effective contributing in project governance meeting to proactively discuss risks, issues related to timelines and quality of deliverables. Present your selected / assigned topic in lecture series internal and / or across line functions thereby improving the statistical knowledge and presentation skills. Use Advanced analytical methods & tools to provide dashboards to the stakeholders. Customer Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables About You Experience : Master's degree 8 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology (preferred) and 4 years. Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines. Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Education : Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology Languages : Excellent English language knowledge – written and spoken Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results. Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Responsibilities BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job Purposes Lead the development and adaptation of health economic models for various markets, focusing on oncology, vaccines, and other pharmaceutical products. Coordinate and manage country-specific adaptations, ensuring quality and compliance with local requirements, while supporting internal teams and external suppliers. Leverage expertise in various modeling techniques and software to provide insights for reimbursement applications, train regional teams, and contribute to project planning and client communications. Responsibilities Key Accountabilities : Coordinate day-to-day activities related to country adaptations in the local regional markets. In alignment with internal Modelling leads, coordinate execution of health economics models for various markets. Participate in discussions regarding the planning of these adaptations and plan for upcoming adaptations. Support the development of project plans for the smooth flow of the adaptations. Support coordination and completion of model request forms and development of all HECON model documents, including but not limited to input sheets. Support administrative tasks associated with health economics modeling in agreement with the client. Ensures quality of health economic model adaptations. Reviews and validates input sheets, and performs quality checks of local adaptations conducted by local suppliers in markets that prefer to use a qualified local supplier or internal Parexel/client staff for model adaptation. Reviews model adaptations report for local submissions and training purposes. Supports training of adapted health economic models for local and regional Operational Research/Market Access teams. Write, refine, review, and critique sections of reports, journal manuscripts, and other deliverables for client or external delivery. Act as primary point of contact and Project Lead, providing guidance and instruction to junior team members while being supported by the Project Director (senior team member). Parexel-Related Responsibilities Professional conduct at all working levels within a client organization and Parexel. Complete basic job-related responsibilities, including timesheets, expense reports, maintenance of CV, project deliverable archiving, etc. Experience And Skills Demonstrated relevant experience in health economics modeling and model adaptations for at least 3 years – this is a must. Able to work across several products/indications in oncology, vaccines, and other global pharma products. Experienced and knowledgeable in model adaptation to review Markov, partition-survival models, discrete-event simulation, etc. Well-versed in reviewing models in different software, e.g., MS Excel, VBA, R (including Shiny), etc. A high degree of written accuracy and attention to detail Good communication skills, both oral and in writing, especially in the relaying of technical information Strong interpersonal, organizational, and communication skills with the ability to interact with individuals from a variety of disciplines. Self-motivation, enthusiasm, ambition, and flexibility Fluent English (additional languages are appreciated) Education Minimum Master's degree, in Health Economics, Biostatistics, Health Services Research, Decision Sciences, Actuarial Sciences, or a closely related, quantitative field.

Job Summary: We are seeking a detail-oriented and proactive Operations Manager to oversee the day-to-day operations of our Clinical SAS Programming team. This role is critical in ensuring the timely delivery of programming outputs, optimizing team workflows, and supporting cross-functional collaboration across clinical development, biostatistics, and data management. Key Responsibilities: Operational Oversight Manage timelines, resource allocation, and deliverables for clinical programming projects. Track progress against milestones and proactively address risks or delays. Ensure compliance with regulatory standards (CDISC, FDA, ICH-GCP). Team Coordination Facilitate communication between programmers, statisticians, and data managers. Support onboarding, training, and performance tracking of programming staff. Promote a culture of accountability, collaboration, and continuous improvement. Process & Quality Management Implement and maintain SOPs, workflows, and documentation standards. Drive automation and efficiency improvements in programming operations. Monitor quality metrics and ensure audit readiness. Stakeholder Engagement Serve as the point of contact for operational updates to leadership and project teams. Coordinate with global teams to align on priorities and resource needs. Support strategic planning and capacity forecasting. Qualifications: Education & Experience Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related field. 7+ years of experience in clinical SAS programming, with 2+ years in a leadership or operations role. Job Summary: We are seeking a detail-oriented and proactive Operations Manager to oversee the day-to-day operations of our Clinical SAS Programming team. This role is critical in ensuring the timely delivery of programming outputs, optimizing team workflows, and supporting cross-functional collaboration across clinical development, biostatistics, and data management. Key Responsibilities: Operational Oversight Manage timelines, resource allocation, and deliverables for clinical programming projects. Track progress against milestones and proactively address risks or delays. Ensure compliance with regulatory standards (CDISC, FDA, ICH-GCP). Team Coordination Facilitate communication between programmers, statisticians, and data managers. Support onboarding, training, and performance tracking of programming staff. Promote a culture of accountability, collaboration, and continuous improvement. Process & Quality Management Implement and maintain SOPs, workflows, and documentation standards. Drive automation and efficiency improvements in programming operations. Monitor quality metrics and ensure audit readiness. Stakeholder Engagement Serve as the point of contact for operational updates to leadership and project teams. Coordinate with global teams to align on priorities and resource needs. Support strategic planning and capacity forecasting. Qualifications: Education & Experience Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related field. 7+ years of experience in clinical SAS programming, with 2+ years in a leadership or operations role. Skills & Competencies Good understanding of clinical trial processes and CDISC standards (SDTM, ADaM). Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira). Excellent organizational, communication, and problem-solving skills. Ability to manage multiple priorities in a fast-paced environment. Preferred Qualifications: PMP or similar project management certification. Experience working in a CRO or pharmaceutical company. Familiarity with regulatory submission processes (e.g., eCTD, define.xml). Good understanding of clinical trial processes and CDISC standards (SDTM, ADaM). Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira). Excellent organizational, communication, and problem-solving skills. Ability to manage multiple priorities in a fast-paced environment. Preferred Qualifications: PMP or similar project management certification. Experience working in a CRO or pharmaceutical company. Familiarity with regulatory submission processes (e.g., eCTD, define.xml).

THE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK .Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team . WHY PHAST ARAccredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environmen t. What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the plan et! THE ROLE Demand for our Functional Service Provision is growing, therefore we are looking for an experienced, ambitious and driven Programmer to join our FSP team The expectation is that the candidate has very strong CDISC knowledge. We're looking for a skilled QC expert with strong experience in ADaMs and TLFs, along with solid SDTM knowledge. This role requires independent work, client coordination, and proactive problem-sol ving.This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environ ment. Responsibi litiesEmployees may be required to perform some or all of the foll owing:Program and validate datasets and SDTMs, including complex efficacy, labs , etc.Become independent technical expertProgram complex non efficacy outputs/ f iguresPerform Senior Review and Deliver QC of non- statistical outputBecome involved in developing the standard macro library and take responsibility to implement standard macros within a studyValidate and perform User Acceptance Testing (UAT) on standard macrosCreate, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISE s, etcImplement and coordinate development and maintenance of PHASTAR standard specific ationsBe an SDTM and ADAM expert providing consultancy, advice and tr ainingBe an CRT expert providing consultancy, advice and tr ainingBe aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requir ementsImplement and coordinate the development and maintenance of PHASTAR CRT toolsBecome familiar with and follow study documen tationInitiating projects and ideas for furthering programming devel opmentEnsure the principles in the PHASTAR checklist are followed rigo rouslyAct as a Lead programmer on multiple studies and project, ensuring quality and timely de liveryLiaise with Study Statistician and Project Manager regarding resourcing and delive rablesResponsible for study level res ourcesAttend and input to company resourcing m eetingPoint of contact for programming issues for the team, proactively ensuring everything is working cohe sivelyPersuade stakeholders to follow best practice within a trialDevelop and deliver company-wide training as and when re quiredIdentify areas where new processes are r equire QUALIFICATIONS & EXP ERIENCE BSc or above in mathematics, science, or IT related dis cipline.Experience working on clinical trials within a CRO/pharmaceutical envi ronment.Excellent proven end to end programming experience including SDTM, ADaM and TLFs with solid experience of validating/reviewing outputsStrong QC ability across ADaMs and TLFs predominantly but good SDTM experienc e neededAbility to work independently and link in with client for work assignments, updated FSP manager on progress/timelines/challenges and feedback QC comments to third part y vendorMust be able to work autonomously as there is no overlap with client teams based in US for day-to-day communication. Has to feel comfortable prioritising tasks and being able to investigate issues and suggest s olutions APPLY NOW With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working en vironment. Should you feel that you have the right skill set and motivations for this position, pl ease apply! Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunit ies for all. Important notice to Employment busines ses/ Agencies Phastar 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 Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. 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 Phastar. Phastar 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.

Business Analyst JD. Responsibilities: Should be responsible and have a good attitude. Must have good written and communication skills in English and Malayalam. Desire to work in a fast-paced, entrepreneurial environment. Should be a fast learner and ready to work on any modules. As a Business System Analyst, you will analyze user needs and data to generate concepts, create prototypes, and iteratively improve solutions. Develop mock-ups and user requirements that IT and technical teams can use to build or enhance solutions. Collaborate with cross-functional teams to gather required data, interpret analysis insights, and explore potential solutions. Document, translate, and communicate findings effectively while advocating for key recommendations. Produce relevant deliverables. Collaborate with client engineering teams to conceptualize, develop, and deploy software solutions by translating business requirements into functional systems. Team up with agile squads, product managers and technical experts to craft business rationales and build proof-of-concept prototypes. Incorporates feedback on prototypes and iterates continuously to improve user experience and customer engagement. Keep abreast of healthcare IT developments encompassing standards, technologies, and workflow methodologies. Helps analyze, organize, and enhance clinical systems and processes to optimize their effectiveness in patient care delivery. Experience in Agile / Scrum methodology. Be a part in presales activities (technical proposal, RFP, POC, estimation and SLA preparation), recruitment. EXPERIENCE REQUIRED: 3 Year - 6 Years Qualification: B.Tech/ B.E/ MCA/ MHA or equivalent (FULL TIME SKILLS REQUIRED: Healthcare Application knowledge is preferred. Understanding of Clinical Data standards. Hands-on design experience with clinical research systems including Clinical Data Management Systems (CDMS), Electronic Health Records (EHR), and Electronic Medical Records (EMR). Bridged clinical research needs with technical capabilities by working closely with biostatistics, regulatory, and IT teams to deliver fit-for-purpose solutions. Experience delivering advanced analytics/machine learning/AI solutions. System Requirements Gathering, Data analysis, Data Engineering and Writing experience (e.g. low fidelity mockups, user stories, storyboards, process flows) Strong analytical skills, willing to learn and apply leading-edge technologies. Hands on experience working in DevOps. Good at Word, Excel and PowerPoint. Good to have knowledge SQL and ANYONE programing language. Job Type: Permanent Pay: Up to ₹1,000,000.00 per year Benefits: Provident Fund Application Question(s): Do you have Healthcare Application knowledge? Experience: DevOps: 2 years (Preferred) Agile: 1 year (Preferred) Scrum: 1 year (Preferred) Business analysis: 4 years (Preferred) Work Location: In person

Description Medical Writing II (CSR Narrative, QC review) 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 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 Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing Good Experience of independent authoring and reviewing CSR Narratives only. 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. 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 Medical Writer II (CSR Narrative exp Only) 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.

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.

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

The Postdoctoral Fellow applicant will work in conjunction with the Principal Investigator to lead the Sex-Based Precision Medicine Research Core (SPMRC). The SPMRC will promote and support sex- and gender-based precision medicine (SPM) research at the Tulane Center of Biomedical Research Excellence in Sex-Based Precision Medicine (COBRE in SPM), assist Research Project Leaders (RPLs) and Pilot Project Leaders (PPLs) in obtaining independent research funding, and serve the broader scientific community by performing high-impact, sex-based biology and precision medicine (SPM) research. The study of sex and gender differences is a discipline in itself, with its own concepts and methods that apply across cells and tissues as well as clinical and population health. This critical aspect of SPM requires the use and knowledge of quantitative methods including biostatistics, epidemiology, and bioinformatics to design and analyze studies to assess the interactions of sex and gender with race, age, and social determinants of health (e.g., occupational hazards, lifestyle, social stresses, access to healthcare).

Founded in 2015, Healthark began as a healthcare and life sciences consulting firm and is rapidly transforming into a tech-first organization specializing in Data Engineering, Data Science, Analytics, Generative AI, and Intelligent Automation. We are a cross-disciplinary team that fuses deep healthcare domain expertise with cutting-edge technological capabilities to tackle complex, data-driven challenges across the healthcare ecosystem. Our services span Growth and GCC Advisory, Real-World Evidence (RWE), digital health innovation, AI/ML solutioning, and the development of modern data platforms. With a team of 150+ consultants, data scientists, engineers, and healthcare experts, we have delivered over 1000 high-impact projects across 60+ global markets. Our clientele includes nimble startups as well as global healthcare and life sciences leaders. From our innovation hubs in Ahmedabad, Bangalore, and Hyderabad, Healthark is driving the next wave of healthcare transformation—leveraging scalable data platforms, automation frameworks, and GenAI-powered insights to deliver measurable outcomes. Position: Biostatistician Experience : 6-10 yrs Location: Hyderabad(Mon-Fri) Company URL: https://healtharkinsights.com Position Overview: We are looking for a skilled and detail-oriented Biostatistician to support Cell and Gene Therapy trials being conducted in India. This role involves developing statistical analysis plans (SAP), conducting interim and final analyses, and ensuring alignment with trial objectives and regulatory requirements. The candidate should have a strong foundation in statistical methodologies, clinical trial regulations, and experience working with multi-disciplinary teams to deliver accurate and meaningful insights from complex clinical data. Key Responsibilities: ● Develop statistical analysis plans (SAPs) aligned with study protocols and endpoints ● Collaborate with study team during protocol development to define study design and statistical considerations ● Perform sample size estimations and power calculations based on trial objectives ● Conduct interim and final statistical analyses, ensuring accuracy, reproducibility, and compliance with applicable standards ● Generate tables, listings, and figures (TLFs) for clinical study reports and publications ● Perform exploratory data analysis and support signal detection, safety review, and efficacy assessments ● Provide statistical input on data collection and case report form (CRF) design ● Work closely with data management team to resolve data issues and ensure data readiness ● Contribute to interpretation of results and preparation of manuscripts, presentations, and regulatory submissions Requirements: ● 6–10 years of experience in biostatistics or clinical trial analytics ● Strong knowledge of statistical methods used in clinical trials, including hypothesis testing, survival analysis, mixed models, and longitudinal data analysis ● Proficiency in statistical programming using SAS or R ● Experience in analyzing clinical trial datasets and interpreting results in a regulatory-compliant environment ● Understanding of trial standards and submission requirements ● Familiarity with protocol design, SAP development, and CRF review ● Ability to communicate complex statistical concepts to non-statistical stakeholders ● Strong documentation, reporting, and analytical skills Skills: ● Familiarity with decentralized or hybrid trial designs ● Experience working with EDC platforms and integrated data environments ● Knowledge of Bayesian methods, adaptive trial designs, or real-world data analysis ● Contributions to peer-reviewed publications or conference presentations Job Type: Full-time Pay: ₹500,000.00 - ₹1,700,000.00 per year Experience: Statistical analysis: 5 years (Preferred) Work Location: In person Application Deadline: 15/08/2025

The University of Hong Kong Apply now Ref.: 532845 Work type: Full-time Department: School of Public Health (22400) Categories: Research Staff Hong Kong Assistant Research Officer in the Hong Kong Jockey Club Global Health Institute (HKJCGHI) of the School of Public Health (Ref. 532845), to commence as soon as possible on a one-year temporary or two-year fixed-term basis, with the possibility of renewal subject to funding availability and satisfactory performance. HKU has partnered with IVI and The University of Cambridge to establish the HKJCGHI, funded by the Hong Kong Jockey Club Charities Trust. IVI is a non-profit international organization dedicated to vaccines and vaccination for global health. The EPIC Unit of IVI coordinates the epidemiology, pandemic preparedness and capacity building work streams of the HKJCGHI. These areas of work are in sync with HKJCGHI activities of the EPIC Unit in Seoul. Applicants should possess a Master’s degree in Epidemiology, Public Health, Biostatistics, or a related field. A PhD degree in a relevant discipline is desirable but not required. Applicants should have 1–3 years of experience in epidemiological research, particularly in the fields of infectious diseases, vaccines, pandemic preparedness or antimicrobial resistance. Applicants should demonstrate strong quantitative skills, including experience with statistical software such as R, SAS, or Stata, and the ability to manage and analyze large epidemiological datasets. Familiarity with the design and implementation of epidemiological studies is highly desirable. They should have excellent written and spoken English skills. Preference will be given to candidates with prior work experience in global health, international organizations, or low- and middle-income country (LMIC) settings. The appointee will contribute to research activities on epidemiology and pandemic preparedness under the HKJCGHI, reporting to the HKJCGHI Epidemiology, Public Health and Impact (EPIC) Program Director in Hong Kong. He/she will work closely with various departments in the EPIC Unit at International Vaccine Institute (IVI) Headquarters in Seoul. Key responsibilities include contributing to designing, implementing and monitoring epidemiological studies related to infectious disease surveillance and pandemic preparedness; managing and analyzing related data to support research objectives; assisting in the development of research protocols, data collection tools, and ethical approvals for studies; contributing to the preparation of research reports, manuscripts for peer-reviewed journals, and presentations for scientific meetings; collaborating with internal and relevant external stakeholders; and supporting capacity-building activities and knowledge translation efforts in LMICs. Additionally, the appointee may be required to support the organization of meetings and to facilitate procurement related to laboratory diagnostics. The appointee is expected to undertake regular international travel to field sites in Africa and Asia to monitor project implementation progress. A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits. Appointees on fixed terms will also receive a contract-end gratuity and University contribution to a retirement benefits scheme totaling up to 10% of basic salary. The University only accepts online application for the above post. Applicants should apply online and upload an up-to-date C.V. Review of applications will start on August 18, 2025, and continue until September 16, 2025 , or until the post is filled, whichever is earlier. Advertised: Aug 5, 2025 (HK Time) Applications close: Sep 15, 2025 (HK Time) Back to search results Apply now Whatsapp Facebook LinkedIn Email App

JOIN AMGEN’S MISSION OF SERVING PATIENTS At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate Vice President, Clinical Data Management Live What You Will Do Let’s do this. Let’s change the world. The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization. The AVP will lead Amgen’s Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases. This AVP will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards. The role requires a visionary leader with deep expertise in CDM and a proven ability to scale and lead global teams in a complex matrix environment. Responsibilities: Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals. Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases. Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows. Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums. Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance. Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization. Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues. Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions. Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics. Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data. Build and maintain strategic relationships with CROs, vendors, regulatory authorities, and industry organizations to advance CDM excellence. Influence internal leadership and functional partners to promote data-driven decision-making across clinical programs. Lead audit readiness efforts and promote a culture of continuous improvement and compliance within the CDM function. Implement protocols and tools to ensure data security, integrity, and risk management across all platforms and studies. Optimize staffing, outsourcing strategies, and technology investments to improve cost-efficiency, scalability, and delivery timelines. Win What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications. Basic Qualifications: Bachelor’s or master’s degree with 25+ years of data management experience AND 10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment. Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM). Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts. Expertise in AI/ML-driven data management solutions, automation, and advanced analytics. Understanding of clinical data standards (CDISC, SDTM, ADaM). Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management. Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams. Experience managing FSP relationships and technology implementations (EDC, CTMS, RWD/RWE). Knowledge of emerging trends in digital health, data governance, and data privacy regulations (GDPR, HIPAA). Familiarity with decentralized trial models and digital health technologies. They will also embody the Amgen leadership attributes which are: Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

JOIN AMGEN’S MISSION OF SERVING PATIENTS At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate Vice President, Clinical Data Management Live What you will do Let’s do this. Let’s change the world. The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization. The AVP will lead Amgen’s Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases. This AVP will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards. The role requires a visionary leader with deep expertise in CDM and a proven ability to scale and lead global teams in a complex matrix environment. Responsibilities: Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals. Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases. Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows. Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums. Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance. Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization. Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues. Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions. Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics. Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data. Build and maintain strategic relationships with CROs, vendors, regulatory authorities, and industry organizations to advance CDM excellence. Influence internal leadership and functional partners to promote data-driven decision-making across clinical programs. Lead audit readiness efforts and promote a culture of continuous improvement and compliance within the CDM function. Implement protocols and tools to ensure data security, integrity, and risk management across all platforms and studies. Optimize staffing, outsourcing strategies, and technology investments to improve cost-efficiency, scalability, and delivery timelines. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications. Basic Qualifications: Bachelor’s or master’s degree with 25+ years of data management experience AND 10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment. Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM). Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts. Expertise in AI/ML-driven data management solutions, automation, and advanced analytics. Understanding of clinical data standards (CDISC, SDTM, ADaM). Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management. Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams. Experience managing FSP relationships and technology implementations (EDC, CTMS, RWD/RWE). Knowledge of emerging trends in digital health, data governance, and data privacy regulations (GDPR, HIPAA). Familiarity with decentralized trial models and digital health technologies. They will also embody the Amgen leadership attributes which are: Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.