Senior Principal Statistical Programmer (ADaM & CDISC Expert)
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25102468
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating the delivery of innovative therapies. By uniting clinical development, medical affairs, and commercial expertise, Syneos Health supports sponsors in navigating complex global markets while improving patient outcomes.
With more than 29,000 professionals operating across 110+ countries, Syneos Health has contributed to the majority of recent FDA and EMA approvals, making it a trusted partner in global clinical research and regulatory submissions.
Role Overview
The Senior Principal Statistical Programmer is a strategic, hands-on leadership role responsible for defining and executing statistical programming strategies across complex, multi-study clinical programs. This position requires advanced expertise in ADaM, CDISC standards, and TLF programming, along with proven capability to independently lead large, global studies and directly engage with sponsor stakeholders.
Key Responsibilities
Technical Leadership and Programming
Provide expert-level leadership in ADaM specification development, programming, review, and validation.
Lead complex ADaM and TLF programming activities, ensuring accuracy, efficiency, and regulatory compliance.
Apply deep knowledge of CDISC standards across Phase I, II, and III clinical trials.
Define programming strategies and best practices across studies, programs, or submissions.
Study and Program Management
Independently lead 4–5 or more end-to-end clinical studies, with full ownership of programming deliverables.
Manage multiple concurrent studies, including large and global trials, with minimal supervision.
Drive timelines, quality, and risk mitigation across studies and portfolios, including exposure to ISS/ISE oversight where applicable.
Client and Stakeholder Engagement
Act as a primary technical contact for sponsors, engaging directly with client statistical and programming leads.
Confidently manage client communications independently, without reliance on US-based intermediaries.
Provide strategic input during submissions, audits, and regulatory interactions.
Innovation and Mentorship
Serve as a subject matter expert (SME) in CDISC and regulatory programming standards.
Identify trends, risks, and improvement opportunities across projects and implement corrective or optimization strategies.
Mentor and guide senior and mid-level programmers, contributing to capability building and process improvement initiatives.
Required Qualifications
Education
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related discipline.
Equivalent education combined with extensive relevant experience will be considered.
Experience
Minimum 10+ years of overall experience in clinical statistical programming within a CRO or pharmaceutical environment.
Demonstrated advanced expertise in ADaM programming and CDISC standards.
Proven experience leading multiple studies independently, including large or global trials.
Strong exposure to multi-phase clinical trials (Phase I–III).
Experience supporting Integrated Summaries (ISS/ISE) is preferred.
Key Skills and Competencies
Expert knowledge of ADaM, CDISC, and regulatory submission requirements.
Strong leadership, strategic thinking, and decision-making capabilities.
Excellent written and verbal communication skills in English.
Ability to influence teams and stakeholders and drive results with minimal oversight.
Strong organizational skills with the ability to manage complex, multi-study environments.
Why Join Syneos Health
Contribute to programs supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Be part of a globally diverse organization that values inclusion, innovation, and professional growth.
Access long-term career development, advanced technical training, and competitive total rewards.
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and is committed to compliance with all applicable employment laws and regulations, including the provision of reasonable accommodations for qualified individuals.
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