Sr Statistical Programmer (ADaM & TLF)
Company: Syneos Health
Location: IND-Hyderabad, India
Work Mode: Hybrid
Employment Type: Full-Time
Job Overview
The Sr Statistical Programmer (ADaM & TLF) is responsible for developing and validating statistical programming outputs for clinical trials, ensuring high-quality deliverables aligned with CDISC standards. The role involves close collaboration with biostatisticians, clinical teams, and sponsors to generate analysis-ready datasets, tables, listings, and figures (TLFs) supporting regulatory submissions and clinical study reports.
Key Responsibilities
Develop SAS programs to generate ADaM datasets, tables, listings, and figures (TLFs) based on SAP and specifications
Ensure accuracy, consistency, and compliance with CDISC standards and regulatory guidelines (ICH, GCP)
Perform validation programming and resolve discrepancies with cross-functional teams
Maintain complete and inspection-ready documentation for all programming activities
Act as lead programmer for assigned studies and guide junior programmers
Manage multiple study timelines, ensuring timely delivery of programming outputs
Participate in study kickoff meetings, sponsor discussions, and bid defenses
Review SAPs, CRFs, mock shells, and specifications for programming feasibility
Contribute to process improvements, SOP updates, and internal training
Ensure adherence to quality standards, company SOPs, and regulatory requirements
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 knowledge of CDISC standards, especially ADaM
Experience generating TLFs for regulatory submissions
Understanding of clinical trial processes and statistical analysis plans
Strong documentation and compliance mindset
Preferred Qualifications
Experience with ISS/ISE or integrated analysis datasets
Exposure to regulatory submissions (FDA/EMA)
Experience mentoring junior programmers or leading study teams
Knowledge of SDTM and data standards beyond ADaM
Experience Required
5–8+ years in statistical programming, preferably in clinical research or CRO/pharma environment
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