Senior Statistical Programmer

Syneos Health

5-8 years

preferred by company

India Pune

10 Feb. 4, 2026

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 Statistical Programmer

Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104964
Employment Type: Full-Time

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers end-to-end solutions that help bring innovative therapies to patients faster. With a presence in over 110 countries and a workforce of more than 29,000 professionals, the company is recognized globally for its impact across clinical research and drug development.

Why Join Syneos Health

Strong focus on employee career development and progression
Supportive leadership and structured technical training
Collaborative, inclusive, and diverse work culture
Exposure to global clinical trials and regulatory-driven projects
Opportunity to work on industry-leading programs that shape patient outcomes

Role Overview

The Senior Statistical Programmer is responsible for leading statistical programming activities for clinical trials, ensuring high-quality, regulatory-compliant outputs. This role involves advanced SAS programming, oversight of programming deliverables, cross-functional collaboration, and mentorship of junior programmers. The position requires strong expertise in clinical trial data, regulatory standards, and statistical programming best practices.

Key Responsibilities

Develop and maintain SAS or other statistical programming code to generate analysis datasets, tables, listings, and figures in accordance with Statistical Analysis Plans (SAPs) and programming specifications.
Ensure programming deliverables meet internal quality standards, sponsor expectations, and regulatory requirements, including ICH guidelines.
Perform validation programming and collaborate with statisticians, programmers, and cross-functional teams to resolve discrepancies efficiently.
Maintain complete and inspection-ready documentation, including QC records, test plans, and validation evidence.
Manage multiple studies simultaneously, balancing timelines, priorities, and deliverables with minimal supervision.
Lead the development of complex dataset and output specifications aligned with sponsor and protocol requirements.
Act as Lead Statistical Programmer, providing technical direction, reviewing deliverables, and monitoring progress of assigned programming team members.
Review study documentation such as SAPs, annotated CRFs, mock shells, and programming specifications, providing proactive feedback to improve efficiency.
Participate in sponsor meetings, kickoff meetings, and bid defense discussions as a statistical programming subject matter expert.
Mentor and support junior programmers through training, code reviews, and process guidance.
Contribute to continuous improvement initiatives, training materials, and internal process enhancements.
Perform additional duties as assigned; minimal travel may be required.

Required Experience and Qualifications

Education: Bachelor’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related discipline; equivalent experience will be considered.
Experience: Minimum 5–8 years of hands-on statistical programming experience in a clinical trial or CRO environment.
Extensive experience with SAS programming; exposure to other statistical tools is an advantage.
Strong understanding of clinical trial data standards, regulatory submission requirements, and validation practices.
Proven experience working with statisticians and cross-functional clinical teams.
Excellent written and verbal communication skills in English.
Ability to manage complex projects independently while meeting tight timelines.

About Syneos Health’s Impact

Over the past five years, Syneos Health has supported:

94% of all novel FDA-approved drugs
95% of EMA-authorized products
More than 200 clinical studies across 73,000 sites and 675,000+ trial participants

Additional Information

This job description outlines the primary responsibilities of the role but is not exhaustive. Syneos Health reserves the right to assign additional duties as required. The company is an equal opportunity employer and is committed to compliance with all applicable employment laws, including providing reasonable accommodations where appropriate.

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Senior Statistical Programmer

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