Company: Syneos Health
Location: India
Experience: SAS programming, CDISC standards, clinical trials
Syneos Health is a global biopharmaceutical solutions provider with 29,000 employees across 110 countries, delivering innovation in clinical development to improve patient outcomes.
Join us—because work here matters everywhere.
The Principal Statistical Programmer is responsible for leading clinical trial programming using SAS and ensuring compliance with CDISC standards. The role involves creating statistical outputs, managing timelines, mentoring junior programmers, and supporting regulatory submissions.
Develop SAS programming code for tables, listings, graphs, and derived datasets based on the Statistical Analysis Plan (SAP).
Perform validation programming, troubleshoot errors, and resolve discrepancies.
Ensure programming outputs meet quality standards and regulatory requirements (ICH, FDA, EMA).
Maintain well-organized project documentation, testing, and verification records.
Serve as Lead Statistical Programmer on multiple global projects.
Collaborate with biostatisticians, sponsors, and project teams to develop specifications and programming solutions.
Review Statistical Analysis Plans (SAPs), programming specifications, annotated CRFs, and database designs.
Participate in sponsor meetings, kickoff meetings, and bid defenses as the statistical programming representative.
Develop standard operating procedures (SOPs), guidelines, and programming tools to improve efficiency.
Ensure CDISC compliance (SDTM, ADaM, and DEFINE.XML) and perform compliance reviews.
Actively participate in industry standards organizations and update teams on regulatory changes.
Mentor junior programmers and conduct training sessions on clinical trial programming and CDISC standards.
Provide feedback and support to enhance team development.
Undergraduate degree in statistics, mathematics, computer science, or a related field (or equivalent experience).
Extensive experience in SAS programming in a clinical trial environment.
Strong knowledge of CDISC standards (SDTM, ADaM) and experience with regulatory submissions.
Proficiency in SAS and other relevant programming tools.
Excellent problem-solving skills and ability to manage multiple projects.
Strong communication skills (written and verbal) in English.
Minimal travel required.
Experience mentoring junior programmers preferred.
Worked on 94% of all Novel FDA-Approved Drugs in the past five years.
Collaborated on 95% of EMA-Authorized Products and 200+ studies across 73,000 sites.
Competitive career growth, mentorship, and rewards program.
Be part of a diverse, inclusive, and innovative workplace.
If you have relevant experience, apply now or join our Talent Network for future opportunities at Syneos Health.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Siliguri |Illinois :
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