Senior Statistical Programmer (SDTM, ADaM, TLF) – Hybrid
Location: Hyderabad / Gurugram, India (Hybrid)
Employment Type: Full-Time
Job ID: 25103420
Last Updated: December 10, 2025
Job Summary
Syneos Health is hiring a Senior Statistical Programmer (SDTM, ADaM, TLF) to support global clinical development programs. This role is ideal for experienced SAS programmers with strong expertise in CDISC standards, clinical trial data, and regulatory deliverables, who can independently manage complex studies while collaborating closely with Biostatistics and cross-functional teams.
The position offers a hybrid work model based in Hyderabad or Gurugram, India, and provides exposure to high-impact global clinical trials.
About Syneos Health
Syneos Health is a leading integrated biopharmaceutical solutions organization, combining clinical development, medical affairs, and commercial capabilities. With a presence in over 110 countries and involvement in the majority of recently approved FDA and EMA products, Syneos Health is committed to accelerating the delivery of therapies that improve patient lives worldwide.
Key Responsibilities
Develop, validate, and maintain SAS programs to generate SDTM, ADaM datasets, tables, listings, and figures (TLFs) as per SAPs and programming specifications
Ensure all programming outputs meet quality, regulatory, and sponsor requirements
Perform validation programming and resolve discrepancies in collaboration with programmers and biostatisticians
Maintain complete, accurate, and inspection-ready programming documentation, QC records, and deliverables
Apply applicable SOPs, Work Instructions, and regulatory guidelines including ICH and CDISC standards
Manage multiple studies concurrently, adjusting priorities and timelines as project needs evolve
Develop dataset and output specifications of moderate to high complexity with minimal rework
Participate actively in internal meetings, contributing technical insights and supporting collaborative decision-making
Act as a study-level lead programmer, reviewing work of junior programmers and monitoring deliverable progress
Review key study documents including SAPs, annotated CRFs, mock shells, and programming specifications
Participate in sponsor interactions, study kickoffs, and bid defense meetings when required
Mentor junior statistical programmers through training, feedback, and technical guidance
Support knowledge sharing, process improvement, and standardization initiatives
Transfer final deliverables and perform additional programming-related duties as assigned
Minimal travel may be required
Required Qualifications & Experience
Bachelor’s degree in Statistics, Mathematics, Life Sciences, Computer Science, or a related discipline
(Equivalent education and relevant experience will be considered)
6–10 years of statistical programming experience in a clinical trials, CRO, or pharmaceutical environment
Strong hands-on expertise in SAS programming
Proven experience working with CDISC standards, including SDTM, ADaM, and TLFs
Experience supporting regulatory submissions and inspection-ready deliverables preferred
Ability to independently manage study-level programming activities
Prior experience guiding or mentoring junior programmers is an advantage
Excellent written and verbal communication skills in English
Strong organizational skills with the ability to manage multiple priorities effectively
Work Model & Location
Hybrid work model
Base locations: Hyderabad or Gurugram, India
Why Join Syneos Health
Work on global clinical trials with high regulatory and scientific impact
Structured career growth and continuous technical training
Collaborative, inclusive, and performance-driven work culture
Exposure to cutting-edge clinical development and submission programs
Competitive compensation and comprehensive benefits
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and is committed to providing an inclusive and accessible workplace. Reasonable accommodations will be provided in accordance with applicable laws.
Apply now on ThePharmaDaily.com to advance your career as a Senior Statistical Programmer with a global biopharmaceutical leader.
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