510 Biostatistics Jobs - Page 5

Skills & Qualifications Exp - 4-6 years in Real world data analysis Qualification - Master's/PhD in statistics, M. Tech, M. Pharma Strong foundation in large database analysis, biostatistics, clinical trial, observational research and epidemiology Experience with handling large databases like administrative claims, electronic health records, patient chart review, Ability to manage multiple projects and deliver results under tight timelines Excellent interpersonal skills and analytical thoughts Tool & Platform Expertise Healthcare coding system ICD9 and 10, HCPCS, CPT, NDC etc. Use programming languages and tools such as SAS, R, R-Shiny, SQL, Python, Power BI Familiarity with RWE platforms like AWS, SAGEMAKER , AZURE and data standards like CDISC Core Responsibilities Data Analysis & Interpretation Analyse large datasets from sources like electronic health records, claims databases, and registries Apply statistical methods to assess patient journey, treatment outcomes, and healthcare utilization and capable to provide key insights and takeaways Study Design & Execution Develop protocols, statistical analysis plans, and research proposals Conduct observational studies and retrospective analyses using real-world data Collaboration & Communication Work cross-functionally with medical affairs, epidemiology, health economics, and commercial teams Excellent presentation skills Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

Skills & Qualifications Exp - 4-6 years in Real world data analysis Qualification - Master’s/PhD in statistics, M. Tech, M. Pharma Strong foundation in large database analysis, biostatistics, clinical trial, observational research and epidemiology Experience with handling large databases like administrative claims, electronic health records, patient chart review, Ability to manage multiple projects and deliver results under tight timelines Excellent interpersonal skills and analytical thoughts Tool & Platform Expertise Healthcare coding system ICD9 and 10, HCPCS, CPT, NDC etc. Use programming languages and tools such as SAS, R, R-Shiny, SQL, Python, Power BI Familiarity with RWE platforms like AWS, SAGEMAKER, AZURE and data standards like CDISC Core Responsibilities Data Analysis & Interpretation Analyse large datasets from sources like electronic health records, claims databases, and registries Apply statistical methods to assess patient journey, treatment outcomes, and healthcare utilization and capable to provide key insights and takeaways Study Design & Execution Develop protocols, statistical analysis plans, and research proposals Conduct observational studies and retrospective analyses using real-world data Collaboration & Communication Work cross-functionally with medical affairs, epidemiology, health economics, and commercial teams Excellent presentation skills Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

Company Description Prigance Research LLP is a research-driven organization at the forefront of healthcare and business research, based in India. Our mission is to transform scientific knowledge into impactful real-world solutions through innovation and excellence. We leverage data-driven insights and informed decision-making to optimize research and business processes, fostering strategic growth. We specialize in healthcare, life sciences, and hospital management, providing services ranging from data analysis and biostatistics to scientific research writing and market research. Role Description This is a full-time, on-site role for a Writing Specialist based in Jaipur. The Writing Specialist will be responsible for creating, editing, and managing various types of written content, including web content and research documents. The role involves conducting thorough research, producing creative and technical writing, and ensuring clear and effective communication. Day-to-day tasks will include drafting content for scientific publications, preparing reports, and collaborating with other teams to refine and polish written materials. Qualifications Proficiency in Writing, Creative Writing, Proof-reading, and Web Content Writing Strong Research skills and the ability to gather, analyze, and interpret data Excellent Communication skills, both written and verbal Experience in scientific or technical writing is advantageous Master's or PhD degree in English, Journalism, Communications, or a related field Ability to work independently and meet deadlines Detail-oriented with strong proofreading and editing abilities Familiarity with the healthcare, business management, or pharmaceutical industries is a plus

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, IN022 Hyderabad, PENJERLA, Telangana, India Job Description: Principal Responsibilities: Designs and develops statistical programs in support of clinical research analysis and reporting activities. Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities. Maintains statistical programming documentation as appropriate. Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables. Performs activities in compliance with departmental processes and procedures. Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals. Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships: Reports into people manager position within the functional area. Accountable to the Programming Lead for assigned programming activities Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, Clinical – Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications - External Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field. In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred. Working knowledge of processes and concepts relevant to Statistical Programming. Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated written and verbal communication skills. Experience working in a team environment.

Ct HR Lavanya - 9566157632 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility: All (UG/PG) Life Science& Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre & Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology & Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident & Emergency Care Technology Audiology & speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre & Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident & Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre & Anaesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology & Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement: Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Tirumala,Tirupati,Hyderabad,Vizag,Eluru,Kakinada,Ongole,Anantpur,Bhimavaram,Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Reach Us: Ct: HR Lavanya - 9566157632

As a Medical Writer Group Lead , you will play a pivotal role in the development of high-quality clinical and regulatory documents across multiple therapeutic areas. Working in close collaboration with sponsors and internal cross-functional teams, you will be responsible for authoring and delivering key documents such as Clinical Study Reports (CSRs), Patient Narratives, Investigator’s Brochures (IBs), Protocols , and more—supporting end-to-end clinical trial documentation and regulatory submissions. Key Responsibilities: • Prepare, write, and review a range of clinical and regulatory documents in compliance with ICH-GCP, sponsor-specific templates, and global regulatory requirements. • Deliver high-quality, accurate, and scientifically sound documents including: • Clinical Study Reports (CSRs) • Patient Safety Narratives • Investigator’s Brochures (IBs) • Clinical Study Protocols and Amendments • Protocol Synopses, Clinical Trial Summaries, and other regulatory submissions • Interpret and present clinical data from statistical tables, listings, and figures. • Liaise with cross-functional teams including clinical, biostatistics, pharmacovigilance, and project management to ensure timely document delivery. • Communicate effectively with sponsor teams and manage feedback and revisions collaboratively. • Maintain version control and ensure adherence to timelines, SOPs, and quality standards. Qualifications: • Bachelor’s, Master’s, or PhD in Life Sciences, Pharmacy, Medicine, or a related discipline. • Minimum 8 - 12 years of medical writing experience in a CRO or similar clinical research environment. • Demonstrated experience with ICH guidelines and global regulatory requirements. • Proficiency in MS Office (Word, Excel, PowerPoint) and familiarity with document management systems. • Excellent written and verbal communication skills. • Strong analytical and organizational skills, with the ability to manage multiple projects simultaneously. Preferred: • Experience with eCTD submissions and regulatory agency interactions. • Familiarity with therapeutic areas such as oncology, CNS, cardiovascular, or rare diseases. • Knowledge of tools like Adobe Acrobat Pro, and referencing software.

This role supports the generation of evidence from patient-reported outcomes across multiple therapeutic areas, with a strong emphasis on oncology. The ideal candidate will have hands-on experience with clinical trial data, deep familiarity with PRO instruments, and strong SAS programming skills. Knowledge of CDARS and experience working in a global, cross-functional environment are essential. Key Responsibilities Develop, validate, and maintain SAS programs for PRO data analysis, including derivation of endpoints, generation of TLFs, and QC of outputs Collaborate with statisticians, study leads, and cross-functional teams to interpret protocols and SAPs, define specifications, and deliver high-quality outputs Support the development and maintenance of standard templates and macros for common PRO instruments (e.g., EQ-5D, EORTC QLQ-C30, FACT-G) Participate in the creation and refinement of guidance documents, SOPs, and training materials for PRO programming workflows Ensure compliance with internal quality standards and regulatory expectations, including documentation of programming logic and QC processes Engage in biweekly PRO team meetings to share updates, troubleshoot issues, and align on priorities Required Qualifications Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, or a related field 3–5 years of experience in statistical programming with a focus on clinical trial data and PRO endpoints Proficiency in SAS; working knowledge of R is a plus Strong understanding of CDARS and familiarity with CDISC standards Experience with multiple therapeutic areas; oncology experience is highly preferred Ability to work independently and collaboratively across time zones in a multicultural environment Preferred Qualifications Familiarity with regulatory guidance on PROs and clinical outcome assessments Experience with automation tools and version control systems (e.g., Git) Exposure to project management tools like Monday.com

Company Description WNS (Holdings) Limited (NYSE: WNS), is a leading Business Process Management (BPM) company. We combine our deep industry knowledge with technology and analytics expertise to co-create innovative, digital-led transformational solutions with clients across 10 industries. We enable businesses in Travel, Insurance, Banking and Financial Services, Manufacturing, Retail and Consumer Packaged Goods, Shipping and Logistics, Healthcare, and Utilities to re-imagine their digital future and transform their outcomes with operational excellence.We deliver an entire spectrum of BPM services in finance and accounting, procurement, customer interaction services and human resources leveraging collaborative models that are tailored to address the unique business challenges of each client. We co-create and execute the future vision of 400+ clients with the help of our 44,000+ employees. Job Description The Epidemiologist Health Data Scientist will assess the feasibility of utilising existing real world data sources such as electronic health records registries claims and social media data to support the generation of real world evidence for consumer health products This assessment will help identify potential applications for RWE studies that use these data sources to aid research and decision making Qualifications MSc or PhD in Epidemiology Biostatistics Health Data Science

Company Description Abiogenesis Clinpharm Private Limited is a leading Contract Research Organization (CRO) providing clinical trial services for the clinical development of biologics, vaccines, medical devices, herbal and nutraceutical products. Our experienced team has conducted national and international clinical trials across all phases of clinical development. From early proof of concept to late-phase development, including post-launch product lifecycle management, we ensure quality work. Our core services include Clinical Operation, Data Management, Biostatistics, Regulatory Affairs, Medical Affairs, Quality Assurance, Pharmacovigilance, and Project Management. Role Description This is a full-time, on-site role for a Business Development Executive, located in Hyderabad. The Business Development Executive will be responsible for identifying new business opportunities, generating leads, and managing accounts. Day-to-day tasks will include developing and implementing business strategies, building and maintaining client relationships, and communicating with internal and external stakeholders. The role also involves coordinating with different departments to ensure client satisfaction and business growth. Qualifications Skills in New Business Development and Lead Generation Experience in Business and Account Management Excellent Communication skills Ability to work on-site in Hyderabad and collaborate with a diverse team Bachelor’s degree in Business Administration, Marketing, or a related field Previous experience in the healthcare or clinical research industry is a must

You will be responsible for planning and executing statistical programming and quality control (QC) of all studies and real-world data insights as relevant. Your accountability will include programming simple to moderately complex studies, ensuring "first time right" mindset for high-quality deliverables, and upholding quality assurance processes to maintain high standards. You will create specification documents for programming and drive stakeholder engagement. Additionally, you will lead, mentor, and manage the performance of the Real-World Programming team, identifying training and development needs, providing constructive feedback, motivating team members, and recognizing their efforts. Acting as a programming Lead for one of the disease areas, you will work hands-on in projects and strategize stakeholder engagement. You will collaborate with cross-functional teams to design and execute programming strategy for real-world evidence studies, stay updated with the latest developments in statistical programming and real-world evidence, and build a recruitment strategy to attract exceptional talent. Your role will involve ensuring team members take accountability of their work, planning and implementing trainings for new technologies, and fostering a culture of ownership and accountability within the team. To qualify for this role, you must have an advanced degree (master's or Ph.D.) in Life Sciences, Epidemiology, Biostatistics, Public Health, Computer Sciences, Mathematics, Statistics, or a related field with applicable experience. You should have a proven track record of leading and managing high-performing teams for real-world evidence projects, experience with real-world databases, expertise in programming languages such as R, SQL, or Python, and familiarity with statistical and epidemiological concepts. Strong leadership, communication, problem-solving, and interpersonal skills are essential, along with a growth mindset and commitment to continuous learning and development. At GSK, we unite science, technology, and talent to get ahead of disease together. As a global biopharma company, we focus on preventing and treating disease with vaccines, specialty and general medicines. Our success depends on our people, and we strive to create an inclusive environment where individuals can thrive, grow, and contribute to our mission of getting Ahead Together. Please note that GSK does not accept referrals from employment businesses/agencies without prior written authorization. If you receive unsolicited emails or job advertisements from non-GSK email addresses, please inform us at askus@gsk.com to verify the authenticity of the job offer.,

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 Minimum 5 years of experience in Project Management. Must possess excellent communication skills and should be proficient in Microsoft Office. Should have prior experience in team handling. Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects Qualifications Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred 3-5 years of relevant experience in science, technical, or medical writing Experience working in the biopharmaceutical, device, or contract research organization industry required Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus Leading the clear and accurate completion of medical writing deliverables Managing medical writing activities associated with individual studies Coordinating these activities within and across departments Completing a variety of documents, adhering to established regulatory standards Coordinating quality and editorial reviews Acting as peer reviewers for the internal team Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs Performing online clinical literature searches and complying with copyright requirements Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentoring and leading less experienced medical writers on complex projects Developing deep expertise on key topics in the industry and regulatory requirements Working within budget specifications for assigned projects

Description 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 Minimum 5 years of experience in Project Management. Must possess excellent communication skills and should be proficient in Microsoft Office. Should have prior experience in team handling. Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects Qualifications Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred 3-5 years of relevant experience in science, technical, or medical writing Experience working in the biopharmaceutical, device, or contract research organization industry required Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus Leading the clear and accurate completion of medical writing deliverables Managing medical writing activities associated with individual studies Coordinating these activities within and across departments Completing a variety of documents, adhering to established regulatory standards Coordinating quality and editorial reviews Acting as peer reviewers for the internal team Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs Performing online clinical literature searches and complying with copyright requirements Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentoring and leading less experienced medical writers on complex projects Developing deep expertise on key topics in the industry and regulatory requirements Working within budget specifications for assigned projects

Position Code : IIPHH-RA-004-2025 Position Title : Research Assistant /Scientist D – Epidemiology No. of Positions : 1 Location : IIPH Hyderabad Duration of Position : 1 Year or Co-terminus with the project Brief On The Organization The Institute of Public Health Sciences Hyderabad (IPHSH) is a society registered under Telangana society’s registration Act 2001 and is managed by an empowered governing board comprising of corporate leaders, civil society representatives and eminent academic and scientific leaders. IPHSH’s core mission areas include: establishing and governing the Indian Institute of Public Health-Hyderabad for developing public health workforce; advancing public health research and technology; and strengthening health systems through evidence informed practice and policy. The Indian Institute of Public Health (IIPH) Hyderabad commenced with a mission to deliver public health education, pursue research and advocacy and support policy development. It lays strong emphasis on pursuing public health policy, practice, training and research, positioning its programmes according to the public health priorities of the state and the nation. The institute has brought together a highly qualified and diverse faculty of nationally and internationally trained and extremely motivated public health academics and practitioners. It aims to create an environment that supports excellence in instruction, research and practice. The Indian Institute of Public Health Hyderabad (IIPH-H) as an arm of the Public Health Foundation of India (PHFI) aims to strengthen Public Health in India. The governance of IIPH Hyderabad is managed by a locally empowered society called the Institute of Public Health Sciences Hyderabad (IPHSH). Project Brief To facilitate the process of transparent and evidence informed decision making in the field of health, Government of India has created an institutional arrangement called the Health Technology Assessment in India (HTAIn) under the Department of Health Research (DHR). HTAIn is entrusted with the responsibility to collate and where needed generate evidence related to the clinical effectiveness, cost-effectiveness, and safety of medicines, devices and health programs using the Health Technology Assessment (HTA) approach. Indian Institute of Public Health, Hyderabad has been selected as a hub of HTAIn with the mandate of carrying out HTA for government and various other relevant agencies in that region. Deliverables  Review of literature—scoping, descriptive and systematic review with meta-analysis  Develop and write HTA project proposals  Write reports and manuscripts  Present project brief at ethical and technical committees  Provide overall leadership to HTA projects  Carry out other related activities assigned by PI and other investigators  Liaise With government health department and related agencies such as National Health Mission and HTAIn secretariat  Budgeting  Facilitating data analysis and management of data repository Qualification  Essential: PhD/Masters in Public Health OR PhD/MSc Epidemiology or any equivalent master’s degree Desirable: Publication in reputed peer-reviewed journals will be given weightage Masters or PhD candidates with an MBBS from reputed institutes as graduate degree will be given preference Experience  Essential: Managing Public Health projects or programmes, post-degree, at middle public health professional level for 5 years  For PhD in Public Health or Epidemiology or for other deserving candidates experience can be relaxed provided the PhD/Master’s thesis was aligned to any public health project or programme and there are publication(s) from it Competence at biostatistics with fluent use of statistical software (preferably R and STATA)  Excellent Liaoning skills with various government agencies and other stakeholders of health technology assessment  Minimum 2 peer reviewed publications Desirable: MS Office, STATA, R, Rayyan, Treeage Process to apply Please note that Annual Salary (CTC) will commensurate with available skills and fitment of the incumbent as per the selection process. Interested and eligible candidates may send their updated CV to vacancies@iiphh.org Please mention the exact Position Code (IIPHH-RA-004-2025) in the email subject line and fill the Application Form https://docs.google.com/forms/d/e/1FAIpQLSdmXgEQg_asw9jYNzFskZMG4WRM_DQZxO FBZ7EGnvP_T094og/viewform?usp=header Only shortlisted candidates will be contacted for the interview. Last Date of Receipt of Applications: 11 Aug 2025 Remarks  Candidates should have an excellent academic record, good communication skills, a commitment to high quality graduate / post-graduate education.  Mere eligibility will not entitle any candidate for being called for interview.  Persons employed in Government/Semi-Government Organization or Educational Institutions in India must apply through proper channel.  IIPHH reserves the right to fill or not to fill any or all available positions.  The requirements of minimum qualification and/or experience may be relaxed in the case of candidates with outstanding credentials.  No correspondence will be entertained from candidates regarding any delays, conduct & result of interview and reasons for not being called for interview. “IIPHH reserves the sole right to alter/modify/cancel the entire selection process or the position or the vacancy or to disqualify any candidature at any stage of the selection process”. Women are encouraged to apply!

Brief on the Organization: The Institute of Public Health Sciences Hyderabad (IPHSH) is a society registered under Telangana society’s registration Act 2001 and is managed by an empowered governing board comprising of corporate leaders, civil society representatives and eminent academic and scientific leaders. IPHSH’s core mission areas include: establishing and governing the Indian Institute of Public Health-Hyderabad for developing public health workforce; advancing public health research and technology; and strengthening health systems through evidence informed practice and policy. The Indian Institute of Public Health (IIPH) Hyderabad commenced with a mission to deliver public health education, pursue research and advocacy and support policy development. It lays strong emphasis on pursuing public health policy, practice, training and research, positioning its programmes according to the public health priorities of the state and the nation. The institute has brought together a highly qualified and diverse faculty of nationally and internationally trained and extremely motivated public health academics and practitioners. It aims to create an environment that supports excellence in instruction, research and practice. The Indian Institute of Public Health Hyderabad (IIPH-H) as an arm of the Public Health Foundation of India (PHFI) aims to strengthen Public Health in India. The governance of IIPH Hyderabad is managed by a locally empowered society called the Institute of Public Health Sciences Hyderabad (IPHSH). Project Brief To facilitate the process of transparent and evidence informed decision making in the field of health, Government of India has created an institutional arrangement called the Health Technology Assessment in India (HTAIn) under the Department of Health Research (DHR). HTAIn is entrusted with the responsibility to collate and where needed generate evidence related to the clinical effectiveness, cost-effectiveness, and safety of medicines, devices and health programs using the Health Technology Assessment (HTA) approach. Indian Institute of Public Health, Hyderabad has been selected as a hub of HTAIn with the mandate of carrying out HTA for government and various other relevant agencies in that region. Deliverables: Review of literature—scoping, descriptive and systematic review with meta-analysis Develop and write HTA project proposals Write reports and manuscripts Present project brief at ethical and technical committees Provide overall leadership to HTA projects Carry out other related activities assigned by PI and other investigators Liaise With government health department and related agencies such as National Health Mission and HTAIn secretariat Budgeting Facilitating data analysis and management of data repository Qualification: Essential: PhD/Masters in Public Health OR PhD/MSc Epidemiology or any equivalent master’s degree. Desirable: Publication in reputed peer-reviewed journals will be given weightage Masters or PhD candidates with an MBBS from reputed institutes as graduate degree will be given preference. Experience: Essential: Managing Public Health projects or programmes, post-degree, at middle public health professional level for 5 years For PhD in Public Health or Epidemiology or for other deserving candidates experience can be relaxed provided the PhD/Master’s thesis was aligned to any public health project or programme and there are publication(s) from it Competence at biostatistics with fluent use of statistical software (preferably R and STATA) Excellent Liaoning skills with various government agencies and other stakeholders of health technology assessment Minimum 2 peer reviewed publications Desirable: MS Office, STATA, R, Rayyan, Treeage Process to Apply: Interested and eligible candidates may send their updated CV to vacancies@iiphh.org Please mention the exact Position Code (IIPHH-RA-004-2025) in the email subject line and fill the application form: https://docs.google.com/forms/d/e/1FAIpQLSdmXgEQg_asw9jYNzFskZMG4WRM_DQZxOFBZ7EGnvP_T094og/viewform?usp=header Only shortlisted candidates will be contacted for the interview. Last Date of Receipt of Applications: 11 Aug 2025 Remarks : Candidates should have an excellent academic record, good communication skills, a commitment to high quality graduate / post-graduate education. Mere eligibility will not entitle any candidate for being called for interview. Persons employed in Government/Semi-Government Organization or Educational Institutions in India must apply through proper channel. IIPHH reserves the right to fill or not to fill any or all available positions. The requirements of minimum qualification and/or experience may be relaxed in the case of candidates with outstanding credentials. No correspondence will be entertained from candidates regarding any delays, conduct & result of interview and reasons for not being called for not being called for interview. Please note that Annual Salary (CTC) will commensurate with available skills and fitment of the incumbent as per the selection process. “ IIPHH reserves the sole right to alter/modify/cancel the entire selection process or the position or the vacancy or to disqualify any candidature at any stage of the selection process ”. Women are encouraged to apply! Code: IIPHH-RA-004-2025 Location: IIPH Hyderabad Category: Fixed Term Salaried Duration of Position: 01 year or co-terminus with the project, whichever is earlier Number of Positions: 1 Last Date: August 11, 2025

You will be joining our team at Fertilica IVF and Woman Care Centre as a Clinical Research Assistant. Your responsibilities will include clinical data collection, statistical analysis, and supporting the creation of scientific publications. Candidates with a background in medical research, data handling, or biostatistics are preferred for this role. Strong communication and writing skills are vital for success in this position. Your key responsibilities will involve coordinating and documenting all aspects of clinical research cycles for fertility patients, managing patient records in compliance with ART and fertility clinic regulations, and overseeing cryostorage administrative tasks. You will also be involved in quality management, data collection, and reporting for ongoing research audits, as well as assisting in planning and executing assisted reproductive technology research practices. Additionally, you will be responsible for drafting, revising, and formatting manuscripts for journal submission, preparing conference presentations, collaborating with investigators on manuscript revisions, and ensuring data accuracy and research transparency compliance. The ideal candidate for this role should possess strong written and oral English skills, exceptional negotiation and organizational abilities, a flexible attitude towards work assignments, proficiency in IT applications, and experience in journal publications. Educational requirements include a Bachelor's or Master's degree in a biological, life science, pharmacy, or other health-related discipline, with knowledge in clinical research methodology. Freshers with a passion for clinical research are encouraged to apply. This is a full-time position based in Hyderabad, offering the opportunity to work in a dynamic environment focused on advancing reproductive technology research and patient care.,

You should have 4-6 years of experience in Real-World Data Analysis and hold a Masters/PhD in Statistics, M.Tech, or M.Pharma. Your expertise should include a strong foundation in large database analysis, biostatistics, clinical trial, observational research, and epidemiology. You must be able to handle large databases such as administrative claims, electronic health records, and patient chart review. Additionally, you should possess the ability to manage multiple projects and deliver results within tight timelines while demonstrating excellent interpersonal skills and analytical thinking. In terms of tools and platforms, you should be proficient in healthcare coding systems like ICD9 and 10, HCPCS, CPT, NDC, etc. You should also have experience with programming languages and tools such as SAS, R, R-Shiny, SQL, Python, and Power BI. Familiarity with Real-World Evidence (RWE) platforms like AWS, SAGEMAKER, AZURE, and data standards like CDISC is a plus. Your core responsibilities will involve data analysis and interpretation, including analyzing large datasets from electronic health records, claims databases, and registries. You will apply statistical methods to assess patient journeys, treatment outcomes, and healthcare utilization to provide key insights. You will also be responsible for developing protocols, statistical analysis plans, and research proposals, conducting observational studies, and retrospective analyses using real-world data. Collaboration and communication skills are essential as you will work cross-functionally with medical affairs, epidemiology, health economics, and commercial teams, showcasing excellent presentation skills. If you do not meet every job requirement, the company encourages you to apply anyway as they are dedicated to building a diverse, inclusive, and authentic workplace. The company offers entry-level full-time positions in Gurugram, Haryana, India, within the Business Consulting and Services sector. You can find more information about the company at http://www.putassoc.com/. Joining this role offers you the opportunity to be part of a company that is committed to creating a diverse, inclusive, and authentic workplace. Your experience may not perfectly align with every qualification, but your excitement about the role could make you the right fit. Apply now and explore the possibilities that await you in this dynamic environment.,

Company Description Agati Clinical is a fast-growing global life sciences services company with a robust portfolio of solutions and services. Specializing in customized clinical staffing solutions and specialized clinical data services, Agati focuses on Data Management, Data Standardization (CDISC), Biostatistics, Statistical Programming, and Regulatory Services. Serving pharmaceutical, biotechnology, and medical device companies, we support all phases of clinical development to ensure success and compliance. Role Description Associate Director, Statistical Programming coordinate and act as a statistical programming subject matter expert for any phase of clinical trial study and/or review of programming deliverables. Provide inputs on effort estimates, review of RFPs, prepare proposal text and attend bid defence meetings as required. Oversee programming team activities, provide technical and project specific guidance to team members, responsible for resource planning/allocation, operational management, recruitment, mentoring subordinates. Role and Responsibilities Promote and adhere to the values of the organization, Integrity, Innovative to Differentiate, Dependable and Trusted Partner, Quality on Time and Grow Collectively Manage or lead multiple project assignments and programming team by acting as point of contact with the Project Management and sponsor team to ensure smooth coordination of the projects Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Company Standard procedures and policies Develop and/or validate specification, programming for CDISC Data Standards, TFL programming for complex studies Develop and manage metrics on a periodic basis to enable sufficient and consistent feedback and identify improvement areas and create a training plan as required Identify changes to the approved project plan and manage through a change control process which reviews impact on timelines, budget and resources Provide inputs on baseline estimations, new business proposals and project plans as required Produce accurate resourcing plans in conjunction with assigned Project Team Members Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed) Timely completion of client specific and organization specific training documentation Workload forecast for the team and provide a vision of the ongoing project objectives or milestones and provide clarity on the upcoming projects Assist in the development and maintenance of the SAS programs/macros, templates and utilities for data cleaning and reporting and to perform Reconciliation of the External data Provide mentorship for associates working on the project and support training requirements for the trainees or team members Involve in process improvement activities to improve the current processes and achieve efficiency and enable the processes are in line with the Regulatory/Industry requirements Setting up challenging, achievable goals for associates which contribute to department objectives and support efforts to achieve those goals Provide timely performance feedback to associates on a routine basis as well as during Annual performance review Supervision on project status, budget expenditures on regular basis, identify any problem and recommend solution Education: Any bachelor’s or master's degree, preferably in computer science, engineering, mathematics, statistics or life science Experience: Minimum 15-18 years of relevant SAS programming experience for all clinical trial phases and demonstrate the ability to independently perform SAS programming Location: Chennai (Or) Bangalore Skills: Proficient in clinical industry standards, CDISC Data standards, ICH-GCP Regulatory guidelines, medical terminology and clinical trial methodologies Proven leadership skills and the ability to lead the statistical programming group by example Strong ability to understand and assess technological and procedural alternatives and the implication of change on current processes Must have strong work ethics and be able to work independently and productively Ability to lead and motivate a team Ability to manage quality and timely customer expectations Excellent communication, organisational, problem-solving skills

Job Description Position: Medical Coder Ct: HR HR Shanmugapriya - 8072891550 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility All (UG/PG) Life Science Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident Emergency Care Technology Audiology speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre Anesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Ct: HR HR Shanmugapriya - 8072891550 This job is provided by Shine.com

Step into a pivotal role where your expertise will shape the future of clinical data science platforms. As a Snr. Specialist in IT Solution Delivery, you will be at the heart of configuring and customizing the SCAPE Statistical Compute Environment (SCE), driving innovation and precision in clinical trials. Collaborating across global teams, you will deliver scalable, compliant solutions that empower data-driven decisions and accelerate breakthroughs in healthcare. Key Responsibilities - Configure, customize, and integrate SCAPE SCE components iteratively to meet business needs. - Design and deliver SCE solutions aligned with architectural standards and operational requirements. - Own delivery of specific SCE components and use cases from concept to execution. - Ensure solution designs support development, execution, and operations of the SCE platform. - Facilitate peer reviews and secure business sign-off on detailed designs. - Uphold security and compliance standards across all service delivery activities. - Collaborate across SCAPE workstreams to ensure timely and budget-conscious delivery. Essential Requirements - Bachelor's degree in Computer Science, Engineering, or a related technical field, or equivalent experience. - Minimum 5 years of experience in IT, with a focus on biostatistics and quantitative science platforms in pharma. - Proven ability to collaborate across global, cross-functional teams and organizational boundaries. - Strong knowledge of Agile, Lean Six Sigma, and Design Thinking methodologies. - Hands-on experience with cloud-based data science platforms and open-source technologies (e.g., R, Python, Docker). - Demonstrated success delivering validated IT solutions at scale in regulated environments. Desirable Requirements - Experience with Domino platform for data science workflows. - Familiarity with EasyBuild tools and AI/ML integration in cloud environments. Benefits & Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Novartis Life Handbook. Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours. You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards. Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours. Commitment To Diversity & Inclusion We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients" lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture. Join our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards.,

The ideal candidate for this position should have a solid background in real-world data analysis with at least 4-6 years of experience. A Master's or PhD in statistics, M.Tech, or M.Pharma is required. You should possess a strong foundation in large database analysis, biostatistics, clinical trial, observational research, and epidemiology. Experience in handling large databases such as administrative claims, electronic health records, and patient chart review is crucial. You must have the ability to manage multiple projects effectively and deliver results within tight deadlines. Strong interpersonal skills and analytical thinking are essential for this role. In terms of tools and platforms, proficiency in healthcare coding systems like ICD9 and 10, HCPCS, CPT, NDC, etc., is necessary. You should be familiar with programming languages and tools such as SAS, R, R-Shiny, SQL, Python, and Power BI. Additionally, knowledge of real-world evidence (RWE) platforms like AWS, SAGEMAKER, AZURE, and data standards like CDISC would be beneficial. Your core responsibilities will include analyzing and interpreting large datasets from sources like electronic health records, claims databases, and registries. You will apply statistical methods to assess patient journeys, treatment outcomes, and healthcare utilization, providing key insights and takeaways. Furthermore, you will be involved in developing protocols, statistical analysis plans, and research proposals, as well as conducting observational studies and retrospective analyses using real-world data. Collaboration and communication skills are essential as you will work cross-functionally with medical affairs, epidemiology, health economics, and commercial teams. Excellent presentation skills are also required for effectively communicating findings and insights. If you do not meet every job requirement listed but are excited about the role, we encourage you to apply anyway. Our company is committed to fostering a diverse, inclusive, and authentic workplace, and you may be the perfect fit for this role or others within the organization.,

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Scientific Director, Clinical Pharmacology Scientific Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD) strategies from the early to late-stage clinical development. This role represents the CP Expert Team to the global cross functional drug discovery and development project teams, in close collaboration with colleagues in Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization. The CP Expert Team Lead provides strong leadership for integrating individual functional contributions, developing clinical pharmacology strategy in alignment with the overall clinical development plan, and executing the program strategy/plan. The scope includes programs from exploratory development (ED) through life cycle management, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas. KEY ACCOUNTABILITIES Ensures that CP strategy is developed, aligned (with cross-functional development plans), endorsed and executed to support the indication, patient population, and phase of development while taking into account the competitive landscape Represent clinical pharmacology and promote MIDD with internal and external stakeholders Provides in-depth CP, PK and PK/PD advice and expertise and lead clinical pharmacology expert team and deliver on Dose and posology decisions, from FIH starting dose through submission and beyond Fit-for-purpose CP package including dose, dose regimen, and adjustment for specific conditions and specific populations, exposure-QTc assessment and immunogenicity assessment in collaboration with other function lines at appropriate stages of development Develop and execute MIDD strategies/plans in collaboration with pharmacometrics and other functions PK/PD data analysis, interpretation, and presentation Related sections of major clinical and regulatory documents (e.g. clinical protocols, IBs, CTDs, INDs, NDAs, IMPDs, briefing books) Contribute to due diligence projects, if needed EDUCATION/LANGUAGES 7+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with clinical drug development experience Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of clinical pharmacology, pharmaceutics, pharmacometrics, statistics, engineering or mathematics Fluency in English PROFESSIONAL SKILLS & EXPERIENCE Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas. Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc. Excellent knowledge of regulatory requirements and submission across the main regions Good understanding about translational sciences such as quantitative pharmacology, safety and biomarkers. Clear evidence of ability to adapt to changing business needs by prioritizing multiple tasks. General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus. Hands on modeling expertise is a plus. Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment. Demonstrated ability for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results. Strong presentation, communication, and organization skills. Ability to communicate technical results to stakeholders. have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Skills & Qualifications Exp - 4-6 years in Real world data analysis Qualification - Master’s/PhD in statistics, M. Tech, M. Pharma Strong foundation in large database analysis, biostatistics, clinical trial, observational research and epidemiology Experience with handling large databases like administrative claims, electronic health records, patient chart review, Ability to manage multiple projects and deliver results under tight timelines Excellent interpersonal skills and analytical thoughts Tool & Platform Expertise Healthcare coding system ICD9 and 10, HCPCS, CPT, NDC etc. Use programming languages and tools such as SAS, R, R-Shiny, SQL, Python, Power BI Familiarity with RWE platforms like AWS, SAGEMAKER , AZURE and data standards like CDISC Core Responsibilities Data Analysis & Interpretation Analyse large datasets from sources like electronic health records, claims databases, and registries Apply statistical methods to assess patient journey, treatment outcomes, and healthcare utilization and capable to provide key insights and takeaways Study Design & Execution Develop protocols, statistical analysis plans, and research proposals Conduct observational studies and retrospective analyses using real-world data Collaboration & Communication Work cross-functionally with medical affairs, epidemiology, health economics, and commercial teams Excellent presentation skills Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

We are hiring a Clinical Research Assistant to join our Fertilica IVF and Woman Care Centre team. The role involves clinical data collection, statistical analysis, and assisting in drafting scientific publications. Candidates with experience in medical research, data handling, or biostatistics are preferred. Strong communication and writing skills are essential. Key Responsibilities: Coordinate and document all aspects of clinical research cycles for fertility patients, consent forms and statistician work. Maintain accurate and till date patient records, including documenting laboratory procedures and maintaining electronic and paper data in accordance with ART regulations as well as fertility clinic regulations. Manage administrative aspects of cryostorage (frozen eggs, sperm, embryos) and contribute to regulatory compliance processes, including audit preparation and adherence to Human Fertilisation and Embryology Authority (HFEA) or similar guidelines. Participate in quality management, data collection, and reporting for ongoing research audits, protocol updates, and service improvement projects. Assist other clinical and laboratory team members in planning, executing, and delivering best practices in assisted reproductive technology research. Draft, revise, and format manuscripts for journal submission, following IMRaD (Introduction, Methods, Results, and Discussion) or relevant guidelines. Prepare abstracts, conference presentations, and materials for research dissemination. Collaborate with investigators on manuscript revisions, responses to peer review, and journal correspondence. Ensure accuracy of data reporting and compliance with research transparency standards. Skills: Competent in written and oral English Team player with outstanding negotiation and organisational skills A flexible attitude with respect to work assignments and new learnings. IT literature (experience with Microsoft based applications and general knowledge of PC functions) experience in journal publications Eligibility Criteria: Educated to Bachelor's or Master's degree level (biological, life science, pharmacy or other health related discipline preferred), knowledge in clinical research methodology Freshers passionate about building a career in Clinical Research Knowledge of Clinical Research concepts preferred Job Location: Hyderabad Job Type: Full-time Pay: 2.5-3.5LPA

Skills & Qualifications Exp - 4-6 years in Real world data analysis Qualification - Master’s/PhD in statistics, M. Tech, M. Pharma Strong foundation in large database analysis, biostatistics, clinical trial, observational research and epidemiology Experience with handling large databases like administrative claims, electronic health records, patient chart review, Ability to manage multiple projects and deliver results under tight timelines Excellent interpersonal skills and analytical thoughts Tool & Platform Expertise Healthcare coding system ICD9 and 10, HCPCS, CPT, NDC etc. Use programming languages and tools such as SAS, R, R-Shiny, SQL, Python, Power BI Familiarity with RWE platforms like AWS, SAGEMAKER, AZURE and data standards like CDISC Core Responsibilities Data Analysis & Interpretation Analyse large datasets from sources like electronic health records, claims databases, and registries Apply statistical methods to assess patient journey, treatment outcomes, and healthcare utilization and capable to provide key insights and takeaways Study Design & Execution Develop protocols, statistical analysis plans, and research proposals Conduct observational studies and retrospective analyses using real-world data Collaboration & Communication Work cross-functionally with medical affairs, epidemiology, health economics, and commercial teams Excellent presentation skills Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Scientific Director, Clinical Pharmacology Scientific Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD) strategies from the early to late-stage clinical development. This role represents the CP Expert Team to the global cross functional drug discovery and development project teams, in close collaboration with colleagues in Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization. The CP Expert Team Lead provides strong leadership for integrating individual functional contributions, developing clinical pharmacology strategy in alignment with the overall clinical development plan, and executing the program strategy/plan. The scope includes programs from exploratory development (ED) through life cycle management, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas. Key Accountabilities Ensures that CP strategy is developed, aligned (with cross-functional development plans), endorsed and executed to support the indication, patient population, and phase of development while taking into account the competitive landscape Represent clinical pharmacology and promote MIDD with internal and external stakeholders Provides in-depth CP, PK and PK/PD advice and expertise and lead clinical pharmacology expert team and deliver on Dose and posology decisions, from FIH starting dose through submission and beyond Fit-for-purpose CP package including dose, dose regimen, and adjustment for specific conditions and specific populations, exposure-QTc assessment and immunogenicity assessment in collaboration with other function lines at appropriate stages of development Develop and execute MIDD strategies/plans in collaboration with pharmacometrics and other functions PK/PD data analysis, interpretation, and presentation Related sections of major clinical and regulatory documents (e.g. clinical protocols, IBs, CTDs, INDs, NDAs, IMPDs, briefing books) Contribute to due diligence projects, if needed EDUCATION/LANGUAGES 7+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with clinical drug development experience Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of clinical pharmacology, pharmaceutics, pharmacometrics, statistics, engineering or mathematics Fluency in English Professional Skills & Experience Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas. Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc. Excellent knowledge of regulatory requirements and submission across the main regions Good understanding about translational sciences such as quantitative pharmacology, safety and biomarkers. Clear evidence of ability to adapt to changing business needs by prioritizing multiple tasks. General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus. Hands on modeling expertise is a plus. Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment. Demonstrated ability for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results. Strong presentation, communication, and organization skills. Ability to communicate technical results to stakeholders. have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!