Principal Statistical Programmer – SDTM, ADaM & TLF (Hybrid)
Updated: February 3, 2026
Job ID: 25103333-OTHLOC-5206-2DH
Location: Gurugram, Haryana, India
Work Model: Hybrid (Hyderabad & Gurugram)
Employment Type: Full-time
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining expertise across clinical development, medical affairs, and commercial services, Syneos Health delivers innovative, end-to-end solutions that address evolving regulatory, scientific, and market challenges.
With more than 29,000 employees across 110+ countries, Syneos Health places patients and customers at the center of its Clinical Development model, driving efficiency, quality, and impactful outcomes throughout the drug development lifecycle.
Role Overview
The Principal Statistical Programmer – SDTM, ADaM & TLF is a senior technical leadership role responsible for delivering high-quality, regulatory-compliant statistical programming outputs across global clinical trials. This position serves as a subject matter expert in CDISC standards, regulatory submissions, and advanced SAS programming, while providing leadership, mentoring, and strategic oversight across multiple concurrent studies.
Key Responsibilities
Lead end-to-end statistical programming activities using SAS or equivalent software for clinical trials
Develop and validate SDTM, ADaM datasets, and TLFs in alignment with Statistical Analysis Plans and programming specifications
Generate high-quality tables, listings, figures, and derived datasets meeting regulatory and sponsor requirements
Perform and oversee validation programming, resolving discrepancies in collaboration with biostatisticians and cross-functional teams
Ensure compliance with ICH guidelines, CDISC standards, SOPs, and regulatory requirements
Maintain inspection-ready documentation, including programming, testing, QC, and verification records
Manage timelines and priorities across multiple projects, proactively addressing risks and delivery challenges
Develop complex dataset and output specifications with minimal rework and high peer-review acceptance
Act as Lead Statistical Programmer, directing and reviewing the work of other programmers
Review key project documents such as SAPs, annotated CRFs, mock shells, and programming specifications
Participate in sponsor interactions, kickoff meetings, bid defenses, and technical discussions as required
Serve as a CDISC subject matter expert, providing guidance, compliance reviews, and training on SDTM, ADaM, and DEFINE.xml
Contribute to the development of programming tools, macros, SOPs, and process improvements
Mentor and train junior and mid-level programmers, supporting capability development across teams
Collaborate with biostatistics and biometrics leadership to support standardization initiatives
Support data transfers and regulatory submission deliverables
Perform additional responsibilities as assigned; minimal travel may be required
Required Qualifications & Experience
Bachelor’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related scientific discipline
(Equivalent combinations of education and relevant experience may be considered)
Minimum 8–10 years of clinical statistical programming experience within a CRO or pharmaceutical environment
Extensive hands-on expertise in SAS programming for clinical trials
Strong experience delivering SDTM, ADaM, and TLFs for regulatory submissions
Proven ability to lead complex, global studies and manage teams of statistical programmers
Deep understanding of CDISC standards, regulatory agency expectations, and electronic submission requirements
Experience supporting Phase I (non-dedicated), Phase II, Phase III, and Phase IV clinical trials
Prior experience mentoring programmers and delivering technical training
Excellent written and verbal communication skills in English
Why Join Syneos Health
Work on programs supporting the majority of recent FDA-approved and EMA-authorized products
Exposure to global regulatory submissions and complex, high-impact clinical development programs
Strong focus on professional growth, leadership development, and technical excellence
Inclusive, people-centric workplace culture with global career opportunities
Competitive compensation and comprehensive total rewards framework
Additional Information
This job description is not exhaustive. Syneos Health reserves the right to modify responsibilities based on business needs. Equivalent education and experience may be considered. All employment decisions are made in compliance with applicable local and international employment laws and equal opportunity regulations.
Syneos Health is committed to providing reasonable accommodations to qualified individuals with disabilities in accordance with applicable laws.
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