Principal Statistical Programmer (SDTM) – Hyderabad / Gurugram – Hybrid
Location: Hyderabad or Gurugram, India
Job Type: Hybrid
Job ID: 25103392
Updated: Today
Syneos Health is a global, fully integrated biopharmaceutical solutions organization committed to advancing clinical development and accelerating customer success. With a network of 29,000 professionals across 110 countries, Syneos Health applies clinical, medical, and commercial expertise to deliver high-impact outcomes for pharmaceutical and biotechnology partners around the world.
This role offers the opportunity to join a high-performance biometrics team supporting critical statistical programming activities for global clinical trials.
Position Overview
The Principal Statistical Programmer (SDTM) will lead statistical programming activities, drive SDTM development, support regulatory submissions, and provide technical direction across multiple clinical studies. This position requires deep expertise in SDTM, SAS programming, CDISC standards, dataset specifications, and regulatory documentation.
The role involves leadership responsibilities, cross-functional collaboration, and direct interaction with sponsors. It is ideal for candidates with extensive end-to-end SDTM experience and strong technical oversight capabilities.
Key Responsibilities
Statistical Programming and SDTM Development
Develop custom programming code in SAS or related tools to generate tables, listings, datasets, graphs, and derived outputs as per statistical analysis plans and programming specifications.
Perform validation programming and coordinate with programmers and biostatisticians to resolve discrepancies or findings.
Create complex dataset specifications aligned with statistical and sponsor requirements.
Ensure all programming outputs meet quality standards and inspection readiness.
Documentation and Regulatory Compliance
Maintain complete project documentation, testing results, and QC records.
Ensure compliance with ICH guidelines, internal SOPs, and regulatory expectations.
Review essential documents including statistical analysis plans, mock shells, annotated CRFs, and programming specifications.
Leadership and Project Management
Act as lead statistical programmer, directing programming activities and monitoring progress across concurrent projects.
Conduct internal meetings, distribute minutes, and ensure follow-up actions are completed.
Negotiate programming timelines and proactively escalate risks with mitigation plans.
Technical Oversight and Innovation
Serve as a technical expert for CDISC standards including SDTM and ADaM.
Conduct compliance reviews for SDTM deliverables, Define.XML, SDRG, and submission packages.
Contribute to developing programming tools, macros, SOPs, and process improvements.
Mentor junior programming staff, conduct training, and provide feedback.
Cross-Functional Collaboration
Participate in sponsor meetings, bid defenses, and kickoff discussions as the programming representative.
Collaborate with biometrics teams to maintain consistency, quality, and operational standards.
Required Qualifications
Education
Bachelor’s degree in statistics, science, mathematics, computer science, or a related discipline.
In lieu of degree, an equivalent combination of education and minimum 8 years of clinical SAS programming experience with deep SDTM expertise is acceptable.
Experience Required
Minimum 8 years of end-to-end SDTM programming experience, including CRF annotation, specification creation, dataset development, submission package preparation, Pinnacle 21 checks, SDRG preparation, and regulatory submission support.
Extensive knowledge of Base SAS and Advanced SAS programming.
Hands-on experience with trial design datasets.
Experience in CDISC compliance, regulatory submissions, and standards implementation.
Experience leading multiple complex or global biometrics projects.
Mentoring experience in programming teams and clinical data standards.
Preferred Skills
Experience with R programming is an advantage.
Exposure to Functional Service Provider (FSP/FSO) environments is helpful.
Strong understanding of clinical development processes, data structures, and electronic submissions.
Soft Skills
Excellent written and verbal communication skills.
Strong technical leadership and problem-solving capabilities.
Ability to prioritize multiple assignments and meet timelines.
Proficiency in reading, writing, and communicating in English.
Why Join Syneos Health?
Work with an organization involved in 94% of all FDA-approved novel medicines in the last 5 years.
Opportunity to support global trials conducted across 73,000 sites and 675,000+ trial participants.
A people-centric culture with career development support, technical training, and performance recognition programs.
A workplace built on inclusion, belonging, and professional growth.
Additional Information
Job duties may be adjusted based on business needs. Equivalent skills and experience may be considered. Syneos Health complies with all applicable regulations, including workplace accessibility and diversity requirements.
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