Principal Statistical Programmer – Syneos Health, Pune
Job Summary
Syneos Health is seeking a Principal Statistical Programmer in Pune to lead high-impact programming deliverables in clinical trials. This senior role is ideal for professionals experienced in SAS, CDISC (SDTM, ADaM), and regulatory submissions, looking to drive process optimization and mentor global teams. Be at the forefront of data science and clinical research that transforms patient outcomes.
Key Responsibilities
Develop custom SAS code to generate datasets, tables, and listings per SAP.
Perform and oversee validation programming; resolve discrepancies with cross-functional teams.
Lead programming teams on complex or global clinical trial projects.
Set and negotiate project timelines, manage deliverables, and mitigate risks.
Design dataset/output specifications aligned with sponsor and regulatory requirements.
Ensure adherence to GCP, ICH, SOPs, and regulatory programming standards.
Conduct project documentation reviews, provide insights, and improve programming efficiency.
Participate in client meetings, bid defenses, and kickoff discussions as programming representative.
Mentor programming teams; develop and deliver training on clinical processes and CDISC standards.
Act as subject matter expert (SME) on CDISC compliance, DEFINE.XML, and electronic submission requirements.
Contribute to SOP and macro development for process standardization and efficiency.
Required Skills & Qualifications
Bachelor's degree in Statistics, Computer Science, or related scientific field (or equivalent experience).
Extensive SAS programming experience in a clinical trial environment.
Proven leadership in managing large-scale statistical programming deliverables.
Deep understanding of CDISC standards (SDTM, ADaM) and regulatory requirements.
Prior experience with regulatory submissions (FDA, EMA).
Excellent verbal and written communication skills in English.
Strong time management and multi-project coordination abilities.
Certifications (Preferred)
SAS Certified Advanced Programmer or equivalent.
CDISC SDTM/ADaM training or certification.
Perks & Benefits
Work on 94% of all FDA-approved drugs and 95% of EMA-authorized products.
Opportunities for global career growth, mentorship, and advanced technical training.
Collaborative, diverse, and inclusive work culture.
Access to total rewards, peer recognition, and continuous learning platforms.
Flexible work environment and minimal travel requirements.
Company Description
Syneos Health® is a global leader in biopharmaceutical solutions, specializing in clinical development, real-world evidence, and commercialization services. With a presence in over 110 countries and a track record of success with leading pharma innovators, Syneos Health delivers end-to-end data-driven services that bring life-changing therapies to market faster.
Work Mode
On-site – Pune, India
Call to Action
Ready to lead global programming in clinical research?
Apply now for the Principal Statistical Programmer role at Syneos Health and shape the future of biostatistics in the pharmaceutical industry.
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