Principal Statistical Programmer – SDTM, ADaM & TFLs (Hybrid)
Updated: February 3, 2026
Job ID: 25103395-OTHLOC-5206-2DH
Work Location: Gurugram, Haryana, India
Work Mode: Hybrid (Hyderabad / Gurugram)
Employment Type: Full-time
About Syneos Health
Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success. By integrating clinical development, medical affairs, and commercial expertise, Syneos Health delivers comprehensive solutions that address today’s complex healthcare and regulatory landscapes.
With operations across more than 110 countries and a workforce of over 29,000 professionals, Syneos Health places patients and customers at the center of its Clinical Development model, driving innovation, efficiency, and measurable outcomes across the drug development lifecycle.
Role Overview
The Principal Statistical Programmer – SDTM, ADaM & TFLs is a senior-level subject matter expert responsible for end-to-end statistical programming activities across multiple clinical trials. This role provides technical leadership, ensures regulatory compliance, and delivers high-quality CDISC-compliant datasets and outputs to support global regulatory submissions.
The position requires strong expertise in SDTM, ADaM, TFL development, and e-submission deliverables, along with proven leadership and project management capabilities.
Key Responsibilities
Serve as a subject matter expert (SME) for statistical programming with advanced-level review capabilities
Lead end-to-end statistical programming activities, including:
CRF annotation
SDTM, ADaM, and TFL specification development
Programming and validation of SDTM, ADaM datasets, and TFLs
Vendor data integration and data management activities
Regulatory submission support, including DEFINE.xml, SDRG, and ADRG
Provide programming leadership across multiple clinical trials, ensuring quality, compliance, and timely delivery
Apply in-depth knowledge of CDISC standards, regulatory expectations, and clinical trial processes
Support safety and efficacy analyses across multiple therapeutic areas
Collaborate effectively with biostatisticians, data management, medical writing, and clinical teams
Proactively manage timelines, risks, and deliverables in a dynamic, fast-paced environment
Contribute to process optimization, standardization, and continuous improvement initiatives
Mentor junior programmers and provide technical guidance as required
Required Qualifications & Experience
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related discipline
Minimum 8+ years of hands-on experience in clinical SAS/statistical programming within a CRO or pharmaceutical environment
At least 3 years of proven leadership experience managing or leading statistical programming activities across multiple clinical trials
Strong end-to-end experience in SDTM, ADaM, and TFL programming
Extensive knowledge of CDISC standards, regulatory submission requirements, and global guidelines (FDA, EMA)
Experience supporting Phase I (non-dedicated), Phase II, Phase III, and Phase IV clinical trials
Therapeutic area experience in Oncology, Neurology, or other clinical domains
Prior experience working in a Functional Service Outsourcing (FSO) model is preferred
Excellent communication, analytical, and problem-solving skills
Why Join Syneos Health
Opportunity to contribute to a majority of novel FDA-approved and EMA-authorized products
Exposure to global regulatory submissions and complex, high-impact clinical programs
Structured career progression, technical training, and leadership development
Inclusive, diverse, and people-first workplace culture
Competitive compensation and comprehensive total rewards program
Additional Information
This job description is not intended to be exhaustive. Syneos Health reserves the right to modify responsibilities based on business needs. Equivalent combinations of education, skills, and experience may be considered. Employment decisions are made in accordance with applicable local laws and equal opportunity regulations.
Syneos Health is committed to providing reasonable accommodations to qualified individuals with disabilities, in compliance with applicable laws.
Gujarat :
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Greece |North Island :
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Cebu City |Philippines :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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