Principal Statistical Programmer – SDTM, ADaM & TLF (Oncology / Non-Oncology)
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25102640
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical and commercial success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers end-to-end solutions that support innovative therapies and improve patient outcomes worldwide.
With a global workforce of over 29,000 professionals across 110+ countries, Syneos Health operates at the forefront of clinical research, supporting the majority of recently approved FDA and EMA products.
Job Overview
The Principal Statistical Programmer – SDTM, ADaM & TLF will serve as a senior technical leader responsible for end-to-end statistical programming delivery across oncology and non-oncology clinical trials. This role requires deep expertise in clinical data standards, regulatory submissions, and complex study-level deliverables, with responsibility for leading programming activities, mentoring teams, and supporting sponsor interactions.
Key Responsibilities
Lead the development, validation, and delivery of SDTM, ADaM, and TLF programming using Base SAS and Advanced SAS in accordance with Statistical Analysis Plans and programming specifications.
Ensure high-quality, compliant outputs that meet sponsor expectations and global regulatory requirements, including ICH guidelines and internal SOPs.
Perform independent validation, peer review, and quality control of programming deliverables; proactively identify and resolve discrepancies.
Oversee and maintain complete, inspection-ready documentation, including QC records, testing evidence, and programming artifacts.
Manage multiple studies and priorities simultaneously, adapting workloads to meet evolving project timelines and business needs.
Develop and review complex dataset and output specifications, ensuring clarity, accuracy, and efficient downstream programming with minimal rework.
Act as Lead Statistical Programmer, directing and mentoring programming team members, tracking deliverables, and providing technical guidance.
Review key study documentation, including SAPs, annotated CRFs, mock shells, and database designs, and provide strategic input to optimize programming efficiency.
Represent statistical programming in sponsor meetings, study kick-off meetings, and bid defense discussions as required.
Support team development through mentoring, training, code reviews, and knowledge transfer activities.
Contribute to cross-functional initiatives and continuous improvement efforts within the statistical programming function.
Required Qualifications
Education
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related discipline.
Equivalent education combined with relevant professional experience will be considered.
Experience
Minimum 8+ years of hands-on experience in Clinical SAS Programming within a CRO or pharmaceutical environment.
Proven expertise in SDTM, ADaM, and TLF development, including specification creation and end-to-end study delivery.
Demonstrated experience handling safety and efficacy data across multiple phases of clinical trials.
Experience supporting ISS/ISE analyses and integrated summaries.
Prior experience in oncology therapeutic areas is highly preferred; non-oncology experience is also acceptable.
Working knowledge of R programming is an added advantage.
Ability to independently lead studies and manage sponsor-facing deliverables.
Candidates available for immediate joining are strongly preferred.
Technical & Professional Skills
Strong command of Base SAS and Advanced SAS programming.
In-depth understanding of clinical trial data standards and regulatory submission requirements.
Excellent analytical, problem-solving, and organizational skills.
Strong written and verbal communication skills in English.
Ability to collaborate effectively across global, cross-functional teams.
Why Join Syneos Health
Work on studies contributing to 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Join a diverse, inclusive, and globally connected organization committed to professional development and innovation.
Access structured career progression, advanced technical training, and competitive total rewards programs.
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and is committed to compliance with all applicable employment laws and regulations. Reasonable accommodations are provided to qualified individuals with disabilities.
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