🔹 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.
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