Senior Statistical Programmer (SDTM, ADaM, TLF)
Location: India (Remote)
Job Type: Full-Time
Job ID: 25104095
Function: Statistical Programming
Industry: Clinical Research, Biopharmaceuticals, CRO
About the Company
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers innovative solutions that address evolving healthcare challenges and improve patient outcomes worldwide.
With more than 29,000 professionals across 110+ countries, Syneos Health operates at the forefront of clinical research, supporting a significant share of novel FDA-approved and EMA-authorized therapies.
Role Overview
Syneos Health is seeking an experienced Senior Statistical Programmer with strong expertise in SDTM, ADaM, and TLF development to join its global statistical programming team. This is a remote opportunity based in India, ideal for professionals who can independently lead study-level programming activities while ensuring regulatory compliance, data quality, and timely delivery.
The role requires hands-on programming expertise, leadership capability, and the ability to collaborate effectively with biostatisticians, clinical teams, and sponsors.
Key Responsibilities
Develop and maintain SAS and R-based programs to generate SDTM datasets, ADaM datasets, tables, listings, and figures (TLFs) in accordance with Statistical Analysis Plans (SAPs) and programming specifications.
Perform validation programming and ensure outputs meet internal quality standards, sponsor requirements, and regulatory guidelines (ICH, SOPs, WIs).
Maintain complete, inspection-ready documentation including program specifications, validation records, and quality control documentation.
Manage multiple studies simultaneously, setting priorities and adapting workloads to meet changing timelines and project demands.
Develop complex dataset and output specifications aligned with statistical and sponsor requirements, proactively identifying and mitigating programming risks.
Act as Lead Statistical Programmer, directing and reviewing work performed by other programmers and monitoring deliverables for accuracy and efficiency.
Review study documentation such as SAPs, mock shells, annotated CRFs, programming specifications, and database designs to minimize rework.
Participate in sponsor meetings, study kick-offs, bid defenses, and internal reviews as the statistical programming representative.
Contribute to team development by mentoring junior programmers, delivering training, reviewing outputs, and supporting onboarding initiatives.
Collaborate across cross-functional teams to ensure timely completion of programming milestones.
Minimal travel may be required based on project needs.
Required Qualifications and Experience
Undergraduate degree in Statistics, Mathematics, Life Sciences, Computer Science, or a related scientific discipline.
Minimum 5+ years of end-to-end Statistical Programming experience, including SDTM, ADaM, and TLF development.
Mandatory experience as a Lead or Co-Lead Statistical Programmer with the ability to independently manage study-level deliverables.
Proficiency in SAS programming; basic proficiency in R programming is required.
Strong understanding of clinical trial data standards and regulatory expectations.
Excellent written and verbal communication skills with the ability to collaborate in a global, remote environment.
Strong organizational skills with the ability to manage multiple priorities in parallel.
Immediate joiners will be preferred.
Fluency in English (written and spoken) is essential.
Why Join Syneos Health
Work on high-impact clinical trials supporting the majority of recent FDA and EMA-approved therapies.
Remote work opportunity with exposure to global studies and international stakeholders.
Strong focus on career growth, technical training, and leadership development.
Inclusive and supportive workplace culture that values diversity, collaboration, and innovation.
Equal Opportunity Statement
Syneos Health is an equal opportunity employer committed to compliance with all applicable employment laws and regulations. Reasonable accommodations will be provided to qualified individuals with disabilities.
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