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Senior Statistical Programmer - Sdtm Expert

5+ years
Not Disclosed
10 Dec. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Statistical Programmer – SDTM Expert

Location: Hyderabad, India
Updated: December 3, 2025
Job ID: 25103419

Position Overview

Syneos Health is seeking a highly skilled Senior Statistical Programmer – SDTM Expert to join its global clinical development team. This role requires strong expertise in SDTM programming, advanced SAS skills, and proven experience supporting clinical trials. The position offers the opportunity to work within an integrated biopharmaceutical solutions organization that partners with leading global clients to accelerate clinical development.

About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions company combining clinical, medical, and commercial capabilities. With operations in over 110 countries and a workforce of more than 29,000 professionals, the organization focuses on simplifying processes, improving efficiency, and fostering a collaborative environment. Syneos Health emphasizes continuous professional development, diversity of thought, and a culture where individuals can thrive and contribute meaningfully.

Key Responsibilities

  • Develop high-quality programming code using SAS and related tools to produce SDTM datasets, analysis datasets, summary tables, listings, and figures in alignment with study specifications and statistical analysis plans.

  • Perform validation programming, ensure compliance with quality standards, and resolve discrepancies in collaboration with Biostatisticians, Programmers, and cross-functional teams.

  • Maintain accurate and inspection-ready documentation, including programming specifications, testing records, and QC documentation.

  • Manage timelines across multiple concurrent projects, prioritize tasks effectively, and adapt to changes in study requirements or timelines.

  • Create complex dataset and output specifications based on study, statistical, and sponsor needs.

  • Lead study-level programming activities, guide junior programmers, and monitor the progress of deliverables.

  • Review essential study documents, including Statistical Analysis Plans, mock shells, annotated CRFs, and programming specifications, providing proactive feedback to improve efficiency.

  • Participate in sponsor meetings, bid defense sessions, and kickoff discussions as the statistical programming representative.

  • Support training and mentoring initiatives by developing materials, conducting sessions, and providing structured feedback.

  • Perform additional duties as assigned to meet operational needs.

  • Minimal travel may be required.

Required Experience

  • Minimum 5 years of statistical programming experience, with a strong focus on SDTM development.

  • Prior experience serving as a Lead Study Programmer is essential.

  • Familiarity with FSO (Flexible Service Offering) environments is preferred.

  • Exposure to R programming is an advantage.

  • Strong hands-on proficiency in SAS within pharmaceutical or clinical trial settings.

  • Bachelor’s degree in a scientific, statistical, or related discipline; equivalent experience may be considered.

  • Excellent written and verbal communication skills with full professional proficiency in English.

Why Join Syneos Health

  • Career development and growth opportunities across global functions.

  • Structured technical and therapeutic training programs.

  • Supportive work environment promoting collaboration and professional recognition.

  • A culture focused on authenticity, well-being, and diversity of thought.

Additional Information

Responsibilities outlined above are not exhaustive. Syneos Health may modify role expectations based on business needs. Equivalent combinations of skills, education, and experience may be considered. The company adheres to global employment standards, including the EU Equality Directive and the Americans with Disabilities Act, ensuring equitable hiring and reasonable accommodations when appropriate.

Role Summary

The Senior Statistical Programmer – SDTM Expert contributes to the design, development, processing, and delivery of statistical programs that support clinical trials and regulatory submissions. The role involves creating high-quality datasets and outputs, evaluating programming processes for improvement, and applying deep subject-matter expertise to ensure accuracy and efficiency. Individuals may independently manage small teams or oversee specific processes, contributing directly to project success.