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Principal Stat Programmer

8+ years
Not Disclosed
10 July 30, 2025
Job Description
Job Type: Remote 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

 

Principal Statistical Programmer – Remote (India)

Location: Remote – India
Experience: 8+ years in Clinical SAS Programming
Company: Syneos Health
Work Mode: Remote
Job ID: 25003691
Updated: July 25, 2025


Job Summary:

Syneos Health is hiring a Principal Statistical Programmer to lead complex global clinical trial programming projects. If you have extensive experience in SAS, CDISC standards (SDTM, ADaM), and regulatory submissions, and are passionate about clinical data science, this remote opportunity will place you at the forefront of global drug development.


Key Responsibilities:

  • Design and develop SAS programs for summary tables, listings, graphs, and derived datasets

  • Validate and troubleshoot outputs to meet project standards

  • Lead statistical programming activities across global clinical trials

  • Develop datasets and outputs per CDISC and regulatory guidelines

  • Participate in bid defense and project meetings with sponsors

  • Mentor junior programmers and lead internal technical training

  • Maintain documentation for audit-readiness and regulatory compliance

  • Ensure on-time delivery and mitigate project risks

  • Act as subject matter expert for CDISC, SDTM, ADaM, DEFINE.XML

  • Contribute to SOP and macro development for programming standardization


Required Skills & Qualifications:

  • Bachelor’s degree in statistics, computer science, or life sciences (or equivalent experience)

  • 8+ years of hands-on experience in Clinical SAS Programming

  • Strong expertise in CDISC standards – SDTM, ADaM, and regulatory compliance

  • Prior experience with global clinical trial submissions

  • Excellent communication, documentation, and leadership skills

  • Knowledge of ICH-GCP, FDA, and EMA data submission requirements

  • Experience mentoring junior team members

  • Ability to manage multiple global projects concurrently

  • Strong knowledge of DEFINE.XML and regulatory deliverables


Perks & Benefits:

  • 100% Remote Work Flexibility

  • Career advancement and technical training opportunities

  • Global exposure through cross-functional collaborations

  • Inclusive, diverse, and supportive work culture

  • Competitive compensation (salary not disclosed)

  • Access to latest industry tools and standards (SAS, CDISC, etc.)

  • Participation in groundbreaking clinical research


About Syneos Health:

Syneos Health is a global biopharmaceutical solutions leader with over 29,000 employees across 110 countries. The company partners with biotech and pharma innovators to conduct clinical trials and commercialize new treatments that change lives. With expertise across clinical, medical, and commercial sectors, Syneos is at the cutting edge of drug development.


Work Mode:

Remote – Based in India


Call to Action:

Are you ready to lead global statistical programming projects that impact lives?
Apply now to join Syneos Health as a Principal Statistical Programmer and advance your career in clinical data science.