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Senior Statistical Programmer

5-8 years
Not Disclosed
10 Dec. 9, 2025
Job Description
Job Type: Full Time Hybrid 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 Statistical Programmer – Syneos Health

Updated: December 5, 2025
Location: Gurugram, India (Hybrid)
Job ID: 25103396
Role Type: Full-time | Hybrid Work Model

Syneos Health is a globally integrated biopharmaceutical solutions organization designed to accelerate clinical, medical, and commercial outcomes for clients across the world. With operations spanning more than 110 countries, Syneos Health brings innovation, scientific expertise, and deep clinical development experience to deliver impactful results that align with modern healthcare needs.

This role is ideal for experienced statistical programmers who excel in SAS programming, clinical data analysis, and leading programming activities within global clinical studies.


Position Overview

The Senior Statistical Programmer is responsible for developing, validating, and managing statistical programming deliverables across clinical trial projects. The role involves creating datasets, tables, listings, and figures while ensuring compliance with regulatory standards, internal SOPs, and sponsor guidelines. The position also includes leadership responsibilities within the programming team.


Key Responsibilities

Programming and Data Analysis

  • Use SAS or related software to develop custom programming code for creating summary tables, derived datasets, listings, and statistical graphs.

  • Ensure all outputs comply with Statistical Analysis Plans (SAPs), programming specifications, and quality standards.

  • Perform validation programming, identify discrepancies, and collaborate with Biostatisticians and project team members to resolve issues.

Documentation and Compliance

  • Maintain organized and inspection-ready documentation, including test scripts, validation reports, and QC documentation.

  • Follow internal SOPs, Work Instructions, and regulatory guidelines such as ICH and relevant data standards.

Project and Time Management

  • Manage timelines across multiple concurrent projects while adjusting workloads based on changing priorities.

  • Develop programming specifications for outputs of varying complexity and anticipate potential technical challenges.

  • Provide accurate time estimates for project deliverables and ensure timely completion.

Team Leadership and Collaboration

  • Lead programming activities for assigned studies and supervise other programmers as needed.

  • Review SAPs, mock shells, CRFs, database designs, and programming specifications, providing process-improving feedback.

  • Participate in sponsor discussions, project kick-off meetings, and bid defense presentations.

  • Mentor junior programmers, contribute to training programs, and share best practices.

General Responsibilities

  • Conduct effective internal meetings and ensure timely communication of updates and action items.

  • Perform additional project-related duties as assigned.

  • Minimal travel may be required.


Qualifications

  • Bachelor’s degree in Statistics, Computer Science, Life Sciences, or a related scientific discipline.
    (Equivalent education or experience may be considered.)

  • Strong and proven programming experience in SAS, preferably within a clinical trial environment.

  • Solid understanding of clinical data structures, CDISC standards, and statistical principles.

  • Excellent written and verbal communication skills.

  • Ability to read, write, and communicate effectively in English.


Experience Required

  • 5 to 8 years of hands-on experience in statistical programming within clinical research or biostatistics.

  • Experience leading study-level programming activities.

  • Prior involvement in regulatory submissions and global clinical trials is highly desirable.

  • Familiarity with SDTM, ADaM, and FDA/EMA submission requirements is an advantage.


About Syneos Health

Syneos Health has partnered with:

  • 94 percent of Novel FDA-approved drugs in the last five years

  • 95 percent of EMA-authorized products

  • More than 200 global studies across 73,000+ sites and 675,000+ trial participants

Employees at Syneos Health work in a dynamic environment where continuous improvement, scientific innovation, and operational excellence are fundamental.

Learn more at: syneoshealth.com


Additional Information

This job description outlines key responsibilities but is not exhaustive. Syneos Health may assign additional tasks based on evolving business needs. Equivalent experience or skills may be evaluated against formal educational requirements. The company adheres to global equal employment regulations, including the EU Equality Directive and the Americans with Disabilities Act, and supports reasonable workplace accommodations.


Role Summary

The Senior Statistical Programmer contributes to the development of statistical programs and clinical data outputs essential for regulatory submissions and clinical trial reporting. This role demands strong technical expertise, leadership capability, and the ability to interpret and structure complex clinical data to meet global regulatory standards.