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Senior Principal Statistical Programmer

0-2 years
Not Disclosed
10 Nov. 11, 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 Principal Statistical Programmer – Structured Job Description

Updated: November 6, 2025
Location: India – Remote
Job ID: 25102468
Company: Syneos Health®


🔷 About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions company supporting clinical, medical, and commercial programs globally. With 29,000 employees across 110 countries, the organization focuses on innovation, patient-centric development, and a culture where individuals can authentically be themselves.


🔷 Role: Senior Principal Statistical Programmer

✅ Summary of the Role

This role provides advanced statistical programming leadership, consultancy, and hands-on support across clinical studies and submissions. The Senior Principal Statistical Programmer independently drives project delivery, develops programming strategies, influences internal/external stakeholders, and ensures compliance with CDISC and regulatory standards.


🔷 Key Responsibilities

1. Technical Leadership

  • Provide expert statistical programming support across studies and programs.

  • Define overall programming strategies for studies/submissions.

  • Act as subject matter expert (SME) for CDISC and other programming standards.

  • Identify cross-project trends and implement improvements.

2. ADaM & CDISC Expertise

  • Lead creation and review of ADaM specifications.

  • Perform complex ADaM dataset programming and validation.

  • Handle complex TFL (Tables, Listings, Figures) programming tasks.

  • Ensure strict compliance with CDISC standards across projects.

  • Work across multiple phases: Phase I, II, and III.

3. Study Leadership

  • Independently lead 4–5+ full studies (must-have requirement).

  • Manage multiple concurrent global/large clinical trials.

  • End-to-end study delivery with minimal supervision.

  • Provide oversight and coordination across study portfolios (including ISS).

4. Client Interaction

  • Serve as primary technical contact for clients.

  • Manage client communication without dependence on US-based counterparts.

  • Present technical solutions and address client queries confidently.

5. Programming Delivery & Oversight

  • Ensure high-quality datasets, TLFs, and submission-ready outputs.

  • Support statistical analysis, reporting, and submission activities.

  • Mentor and guide junior programmers.

  • Support tools, automation, and innovation initiatives within Biostatistics.


🔷 Required Experience & Technical Skills

🎓 Experience

  • 10+ years total experience in statistical programming in clinical research.

  • Strong exposure to global clinical trials and regulatory submissions.

💡 Must-Have Technical Skills

  • Advanced ADaM expertise (specification, programming, review).

  • Strong mastery in CDISC standards (ADaM, SDTM highly preferred).

  • Complex ADaM + TFL programming experience.

  • Experience across Phases I–III.

✅ Study Management Requirements

  • Must have independently led 4–5+ clinical studies.

  • Experience leading multiple studies simultaneously.

  • Strong ability to drive delivery with minimal oversight.

  • Exposure to large/global trials and multi-study integration workflows.

⭐ Good-to-Have Skills

  • ISS/ISE (Integrated Summary of Safety/Efficacy) experience.

  • Understanding of integration workflows.

  • Exposure to diverse study designs.


🔷 Behavioral & Soft Skills

  • Excellent communication and stakeholder management skills.

  • Ability to work independently with high accountability.

  • Strong problem-solving and decision-making ability.

  • Leadership mindset with mentoring capabilities.


🔷 Additional Information

  • Responsibilities may expand as per business needs.

  • Equivalent experience/education may be considered.

  • Syneos Health complies with ADA and supports reasonable accommodations.

  • Commitment to diversity, inclusion, and equal opportunity employment.