Principal Stat Programmer at Syneos Health – Pune, India
Job Summary
Syneos Health is hiring a Principal Stat Programmer to lead complex statistical programming activities in clinical trials. This role demands expertise in SAS, CDISC Standards (SDTM, ADaM), and regulatory submissions. Ideal for experienced programmers looking to impact global drug development while working with one of the world’s leading biopharmaceutical solution providers.
Key Responsibilities
Develop and validate SAS programs for tables, listings, graphs, and datasets per statistical analysis plans.
Lead programming activities across multiple complex clinical trial projects.
Ensure quality and compliance with ICH, GVP, and company SOPs.
Provide technical leadership to programming teams and mentor junior staff.
Conduct internal and sponsor-related meetings; contribute to project documentation review (e.g., SAP, CRFs, mock shells).
Implement CDISC Standards (SDTM, ADaM) for FDA and other regulatory submissions.
Design, develop, and validate macros, tools, and templates for standardization and efficiency.
Represent statistical programming in sponsor and bid defense meetings.
Maintain inspection-ready project documentation and quality control records.
Required Skills & Qualifications
Bachelor’s degree in Statistics, Computer Science, or related field (or equivalent experience).
Extensive programming expertise in SAS within clinical trial environments.
Proficient in CDISC Standards (SDTM, ADaM) and regulatory submission processes.
Strong leadership, problem-solving, and communication skills.
Ability to mentor and train junior programmers in CDISC and clinical trial processes.
Knowledge of FDA and EMA regulatory submission requirements preferred.
Fluent in English (written and spoken).
Perks & Benefits
Competitive salary and benefits package (compensation range not specified).
Global exposure with projects across 110 countries.
Career development opportunities and technical training.
Total Self culture promoting diversity, equity, and inclusion.
Recognition and rewards programs.
Company Description
Syneos Health® is a global, fully integrated biopharmaceutical solutions provider accelerating client success through clinical development, medical affairs, and commercialization services. With over 29,000 employees in 110 countries, Syneos Health partners with top pharmaceutical companies to deliver innovative and efficient healthcare solutions.
Work Mode
On-site – Pune, Maharashtra, India
Call to Action
Ready to make an impact in clinical drug development? Apply now for the Principal Stat Programmer position at Syneos Health and be part of shaping future healthcare breakthroughs!
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