Sr Statistical Programmer (ADaM & TLF)
Company: Syneos Health
Location: IND-Pune, India
Work Mode: Hybrid
Employment Type: Full-Time
Job Overview
The Sr Statistical Programmer (ADaM & TLF) is responsible for developing, validating, and delivering high-quality statistical programming outputs for clinical trials. The role focuses on ADaM dataset creation and generation of Tables, Listings, and Figures (TLFs) to support clinical study reports and regulatory submissions in compliance with CDISC standards and global regulatory requirements.
Key Responsibilities
Develop SAS programs to create ADaM datasets, TLFs, and derived analysis outputs as per SAP and specifications
Ensure accuracy, consistency, and regulatory compliance of all programming deliverables
Perform validation programming and resolve discrepancies with cross-functional teams
Maintain complete, audit-ready documentation including QC, testing, and validation records
Act as lead statistical programmer for assigned studies or programs
Coordinate programming activities across multiple projects and manage timelines effectively
Review SAPs, CRFs, specifications, mock shells, and dataset designs
Participate in sponsor meetings, study kickoff meetings, and bid defense discussions
Provide mentoring, guidance, and technical support to junior programmers
Contribute to process improvements, SOP updates, and best practices in programming
Required Qualifications
Bachelor’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field
5+ years of SAS programming experience in clinical trials
Strong expertise in CDISC ADaM standards
Experience in generating TLFs for clinical and regulatory submissions
Good understanding of clinical trial processes and statistical analysis plans
Strong documentation, communication, and stakeholder coordination skills
Preferred Qualifications
Experience in ISS/ISE or integrated analysis studies
Exposure to global regulatory submissions (FDA/EMA)
Experience in leading programming teams or mentoring junior staff
Knowledge of SDTM and other clinical data standards
Experience Required
5–8+ years in statistical programming within pharmaceutical/CRO/clinical research domain
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