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Sr Statistical Programmer(Sdtm + Adam + Tlf)

5+ years
Not Disclosed
10 July 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Sr Statistical Programmer (SDTM + ADaM + TLF) – Pune

Job Summary

Syneos Health is hiring an experienced Sr Statistical Programmer to support clinical trial reporting using SAS, SDTM, ADaM, and TLF standards. If you’re ready to apply your 5+ years of clinical SAS programming experience in a global CRO environment, this role offers the chance to work on mission-critical datasets that contribute to the approval of novel therapies across the globe.


Key Responsibilities

  • Develop and validate SDTM, ADaM, and TLF datasets using SAS and related tools

  • Perform programming in accordance with the Statistical Analysis Plan (SAP)

  • Conduct data validations, documentation, and quality control procedures

  • Lead programming activities and mentor junior programmers

  • Participate in sponsor meetings and cross-functional team discussions

  • Maintain audit-ready documentation for regulatory submissions

  • Collaborate with statisticians, data managers, and project leads

  • Ensure adherence to ICH, GCP, and company SOPs and regulatory standards


Required Skills & Qualifications

  • Bachelor’s degree in a scientific/statistical field or equivalent experience

  • Minimum 5+ years of experience in clinical SAS programming

  • Strong proficiency in Base SAS and Advanced SAS

  • Hands-on experience with SDTM, ADaM, and TLF generation

  • Knowledge of clinical trial standards and regulatory guidelines (e.g., ICH-E3)

  • Excellent problem-solving and communication skills

  • Preferred: Exposure to R programming


Perks & Benefits

  • Competitive compensation package (Salary not disclosed)

  • Career progression and professional development

  • Global exposure across 110 countries

  • Access to technical and therapeutic training programs

  • Collaborative and inclusive Total Self culture


Company Description

Syneos Health is a global biopharmaceutical solutions company offering fully integrated services in clinical development, medical affairs, and commercialization. With expertise spanning 94% of all FDA-approved drugs in the last five years, Syneos is at the forefront of healthcare transformation, helping bring new therapies from lab to life.


Work Mode

On-site – Pune, India


Call to Action

If you’re passionate about clinical data and want to make a real impact in global drug development, apply now to join Syneos Health’s growing programming team.

Apply Now