Senior Statistical Programmer (SDTM, ADaM, TLF)
Location: Pune, Maharashtra, India
Job ID: 25104095
Updated: Yesterday
Employment Type: Full-Time
About the Company
Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating the development and commercialization of innovative therapies. With integrated expertise across clinical development, medical affairs, and commercial solutions, Syneos Health partners with customers to deliver meaningful outcomes in a rapidly evolving healthcare landscape.
Operating across more than 110 countries with over 29,000 employees, Syneos Health is recognized for its patient-centric approach, collaborative culture, and commitment to scientific excellence.
Job Overview
Syneos Health is seeking an experienced Senior Statistical Programmer to join its Statistical Programming team in Pune, India. This role is ideal for professionals with strong hands-on expertise in SDTM, ADaM, and TLF development, who can independently manage study-level programming activities and lead statistical programming deliverables in a regulated clinical research environment.
Key Responsibilities
Develop and validate statistical programs using SAS and other relevant tools to generate clinical trial outputs, including tables, listings, figures (TLFs), and derived datasets in accordance with Statistical Analysis Plans (SAPs) and programming specifications.
Lead end-to-end SDTM and ADaM dataset development, ensuring compliance with CDISC standards and regulatory expectations.
Perform independent and peer validation programming to ensure accuracy, quality, and regulatory readiness of all deliverables.
Collaborate closely with Biostatisticians, Clinical Data Management, Medical Writing, and cross-functional project teams to resolve programming issues and discrepancies.
Maintain complete, well-organized, and inspection-ready documentation, including programming code, QC documentation, and validation records.
Manage multiple studies simultaneously, prioritize tasks effectively, and adapt to changing timelines or project requirements.
Review key study documents such as SAPs, mock shells, annotated CRFs, and programming specifications, providing proactive feedback to reduce downstream rework.
Act as Lead or Co-Lead Statistical Programmer on assigned studies, guiding junior programmers and monitoring progress against milestones.
Participate in sponsor interactions, including kickoff meetings, study reviews, and bid defense meetings, as the statistical programming representative.
Contribute to team capability building through mentoring, training delivery, and knowledge sharing initiatives.
Ensure adherence to applicable SOPs, work instructions, and regulatory guidelines, including ICH and global regulatory standards.
Required Qualifications
Education
Bachelor’s degree in Statistics, Mathematics, Life Sciences, Computer Science, or a related scientific discipline.
An equivalent combination of education and relevant statistical programming experience may be considered.
Experience
Minimum 5+ years of end-to-end Statistical Programming experience in the clinical research or pharmaceutical industry.
Proven hands-on expertise in SDTM, ADaM, and TLF development for regulatory submissions.
Mandatory Lead or Co-Lead study experience, with the ability to independently manage study-level programming deliverables.
Working knowledge of R programming is required.
Experience working in a global, regulated environment with strong understanding of data standards and submission readiness.
Immediate or short-notice joiners will be preferred.
Skills and Competencies
Strong analytical, problem-solving, and attention-to-detail skills.
Excellent written and verbal communication skills in English.
Ability to work collaboratively across global, cross-functional teams.
Strong organizational skills with the ability to manage competing priorities effectively.
Why Join Syneos Health
Opportunity to work on studies supporting a significant percentage of FDA- and EMA-approved products.
Exposure to complex, global clinical trials across multiple therapeutic areas.
Strong focus on professional development, technical training, and career progression.
Inclusive and diverse workplace culture that values collaboration, innovation, and individual contribution.
Over the past five years, Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, impacting hundreds of thousands of trial patients worldwide.
Additional Information
The responsibilities listed above are representative but not exhaustive. Syneos Health reserves the right to assign additional duties as needed. Employment decisions are made in compliance with all applicable local and international employment laws, including equal opportunity and disability accommodation requirements. Nothing in this posting constitutes a contract of employment.
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