Principal Statistical Programmer (SDTM) – Hybrid
Location: Hyderabad, India (Hybrid)
Job ID: 25103395
Employment Type: Full-Time
Industry: Clinical Research | Biostatistics | Pharmaceutical Services
Updated On: December 10, 2025
About the Organization
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization dedicated to accelerating the delivery of innovative therapies. By combining deep clinical, medical affairs, and commercial expertise, Syneos Health supports sponsors across the entire product lifecycle.
With operations in over 110 countries and a workforce of more than 29,000 professionals, Syneos Health places patients and customers at the center of its Clinical Development model, delivering streamlined, high-quality clinical research solutions worldwide.
Position Overview
Syneos Health is hiring a Principal Statistical Programmer (SDTM) to lead statistical programming activities for complex and global clinical trials. This senior-level role requires advanced expertise in SAS programming, CDISC standards, and regulatory submissions, along with proven leadership in managing multi-study deliverables.
The position is hybrid-based in Hyderabad, offering an opportunity to work closely with global stakeholders while driving programming excellence across clinical development programs.
Key Responsibilities
Lead development of SAS programs to generate SDTM datasets, tables, listings, figures, and derived outputs in alignment with SAPs and programming specifications.
Ensure high-quality, validated outputs compliant with ICH, CDISC, SOPs, and regulatory guidelines.
Perform and oversee validation programming; resolve discrepancies in collaboration with biostatisticians and cross-functional teams.
Manage multiple concurrent studies, balancing priorities, timelines, and resource allocation.
Develop and review complex dataset and output specifications with minimal rework during peer and sponsor review.
Serve as Lead Statistical Programmer, directing programming teams and monitoring deliverable progress.
Review key study documentation including SAPs, mock shells, annotated CRFs, SDTM/ADaM specifications, and database designs.
Participate in sponsor interactions including kickoff meetings, audits, and bid defense discussions.
Act as a CDISC Subject Matter Expert, providing guidance on SDTM, ADaM, DEFINE.XML, and regulatory submission standards.
Conduct compliance reviews of regulatory deliverables and stay updated on evolving industry standards.
Mentor and train statistical programmers, contributing to skill development and process standardization.
Support development of programming tools, macros, SOPs, and efficiency initiatives.
Required Qualifications & Experience
Bachelor’s degree in Statistics, Life Sciences, Mathematics, or a related scientific discipline; equivalent experience will be considered.
8–12 years of hands-on statistical programming experience, primarily within a clinical trial environment.
Strong expertise in SDTM datasets and in-depth knowledge of CDISC standards for regulatory submissions.
Extensive experience using SAS for clinical trial programming.
Proven ability to lead global, multi-study programming teams and complex clinical programs.
Prior experience supporting FDA/EMA submissions is strongly preferred.
Demonstrated experience mentoring and guiding programming staff.
Excellent written and verbal communication skills in English.
Core Competencies
Advanced analytical and problem-solving capabilities
Strong leadership and stakeholder management skills
High attention to detail and commitment to quality
Ability to work effectively in a matrixed, global environment
Strong understanding of clinical development and regulatory expectations
Why Join Syneos Health
Work on high-impact global clinical trials supporting FDA- and EMA-approved therapies
Hybrid work model offering flexibility and collaboration
Opportunity to serve as a technical leader and industry expert
Inclusive, performance-driven culture with strong career growth opportunities
Job Summary
The Principal Statistical Programmer (SDTM) serves as a senior technical leader responsible for delivering regulatory-compliant clinical datasets, guiding programming teams, and ensuring adherence to global standards. This role requires 8+ years of experience, deep SDTM expertise, and strong leadership capabilities within clinical research programming.
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