Senior Principal Statistical Programmer
Company: Syneos Health
Updated: 06-Nov-2025
Location: Remote – India
Job ID: 25102468
About Syneos Health
Syneos Health is a global biopharmaceutical solutions organization that integrates clinical, medical, and commercial services.
29,000 employees, 110 countries
Worked with 94% of FDA-approved drugs in last 5 years
Worked with 95% of EMA-authorized products
Supported 200+ studies, 73,000 sites, 675,000+ patients
WORK HERE MATTERS EVERYWHERE
Position Overview
The Senior Principal Statistical Programmer provides high-level statistical programming expertise, project leadership, and submission support across clinical studies and programs.
This role requires deep ADaM + CDISC mastery, proven study leadership, and the ability to independently manage client communication.
Experience Requirement
10+ years overall Statistical Programming experience
Strong ADaM & CDISC expertise
Proven track record of leading multiple clinical studies
Technical Skills – Must Have
✅ ADaM Expertise
ADaM specification development
ADaM dataset programming & review
Handling complex ADaM and TFL programming tasks
✅ CDISC Standards
Deep understanding of CDISC standards (SDTM, ADaM)
Experience applying CDISC across Phase I–III trials
✅ Client Interaction
Ability to communicate directly with client technical leads
Can independently manage projects without US-based support
Study Management Requirements
Must have independently led at least 4–5 clinical studies
Ability to lead multiple studies simultaneously (global/large-scale preferred)
Capability to manage end-to-end study delivery with minimal oversight
Exposure to portfolio-level oversight, particularly ISS (Integrated Summaries)
Good-to-Have Skills
Prior ISS (Integrated Summary of Safety/Efficacy) experience
Experience with diverse study designs
Understanding of integration workflows
Key Responsibilities
✅ 1. Statistical Programming Leadership
Provide programming consultancy and technical leadership
Guide ADaM, SDTM, and TFL programming across studies
Develop overall programming strategy for projects/submissions
✅ 2. Project & Submission Management
Support analysis, reporting, and regulatory submission preparation
Lead cross-functional teams to ensure study deliverables
Identify trends across projects and implement improvements
✅ 3. Technical Excellence
Serve as a subject matter expert (SME) for ADaM, CDISC, and industry standards
Drive innovation and improve biostatistics tools and processes
Ensure programming complies with regulatory requirements
✅ 4. Collaboration & Client Engagement
Influence internal teams and clients to achieve quality outcomes
Provide hands-on guidance during complex programming tasks
Lead interactions with sponsors on technical matters
Role Summary
This role combines:
High technical expertise (CDISC, ADaM, regulatory requirements)
Strategic leadership across studies or programs
Hands-on programming when required
Mentorship & SME responsibilities to support the Biostatistics department
A Senior Principal Statistical Programmer acts with full independence, drives end-to-end delivery, and significantly shapes programming strategy and quality across the portfolio.
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