Senior Stat Programmer(Adam & Tlf)

Syneos Health

5+ years

Not Disclosed

India Remote

10 Jan. 7, 2026

Job Description

Job Type: Full Time Remote 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 (ADaM & TLF) – Remote (India)

Location: India (Remote)
Job Type: Full-Time
Experience Required: 5+ Years
Job ID: 25103312
Updated: Today

About the Company

Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining deep clinical, medical affairs, and commercial expertise, Syneos Health delivers impactful outcomes that address evolving market realities.

With operations across more than 110 countries and a workforce of over 29,000 professionals, Syneos Health is known for its patient-centric Clinical Development model and its commitment to innovation, agility, and operational excellence.

Position Overview

Syneos Health is seeking an experienced Senior Statistical Programmer (ADaM & TLF) to support clinical development programs in a remote India-based role. The successful candidate will act as a lead statistical programmer, contributing to high-quality clinical trial deliverables, regulatory submissions, and cross-functional collaboration.

This role is ideal for professionals with strong expertise in clinical statistical programming, ADaM dataset development, and TLF generation within a regulated global environment.

Key Responsibilities

Develop and maintain high-quality statistical programs using Base SAS and Advanced SAS, including SAS Macros, to generate analysis datasets, tables, listings, and figures (TLFs) as per Statistical Analysis Plans (SAPs) and programming specifications.
Create and review ADaM datasets and complex outputs in compliance with sponsor requirements and regulatory standards.
Perform validation programming and quality control checks to ensure accuracy, consistency, and inspection readiness.
Collaborate closely with biostatisticians, clinical teams, and other programmers to resolve discrepancies and address programming issues proactively.
Maintain complete, well-organized, and audit-ready documentation, including programming specifications, QC documentation, and testing records.
Manage multiple projects simultaneously, adapting to changing priorities and timelines while meeting delivery commitments.
Act as Lead Statistical Programmer, overseeing and guiding junior programmers, reviewing deliverables, and ensuring alignment with best practices.
Review key project documents such as SAPs, mock shells, annotated CRFs, and database designs, providing feedback to improve efficiency and quality.
Participate in sponsor meetings, study kick-off meetings, and bid defense discussions as the statistical programming representative.
Support training and mentoring initiatives by developing materials, reviewing work, and guiding new team members.
Ensure compliance with internal SOPs, Work Instructions, and applicable regulatory guidelines, including ICH standards.

Required Qualifications

Bachelor’s degree in a scientific, statistical, or related discipline; equivalent education and relevant experience will be considered.
Minimum 5+ years of experience in Clinical Statistical Programming within a CRO or pharmaceutical environment.
Strong hands-on experience in ADaM and TLF programming.
Proven experience supporting safety and efficacy data analysis and regulatory submission activities.
Advanced proficiency in Base SAS, Advanced SAS, and SAS Macros.
Excellent written and verbal communication skills in English.
Ability to work effectively in a remote, global, cross-functional team environment.

Why Join Syneos Health

Opportunity to work on a majority of novel FDA-approved drugs and EMA-authorized products.
Exposure to large-scale global clinical trials across thousands of sites and patients.
Strong focus on professional development, technical training, and career progression.
Inclusive, diverse, and people-centric culture that values authenticity and collaboration.
Competitive compensation and comprehensive rewards program.

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 needed. The company is an equal opportunity employer and is committed to compliance with all applicable employment and accessibility laws across regions.

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Senior Stat Programmer(Adam & Tlf)

Job Description

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