Senior Statistical Programmer (SDTM) – Hyderabad / Gurugram (Hybrid)
Updated: December 5, 2025
Location: Hyderabad / Gurugram, India (Hybrid Work Model)
Job ID: 25103398
Role Type: Full-time | Clinical Data & Biostatistics
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating clinical, medical, and commercial outcomes. By leveraging insights across clinical development, medical affairs, and commercial operations, Syneos Health ensures innovative therapies reach patients efficiently and safely.
We are seeking a Senior Statistical Programmer (SDTM) with strong SAS programming expertise and end-to-end SDTM experience to join our Hyderabad or Gurugram team under a hybrid working model.
Role Overview
The Senior Statistical Programmer (SDTM) will lead the development, validation, and review of SDTM datasets, tables, listings, and graphs for clinical trials. This role involves close collaboration with statisticians, project managers, and cross-functional clinical teams to ensure regulatory compliance, data quality, and timely delivery of programming outputs.
Key Responsibilities
Clinical Programming & SDTM Development
Develop, validate, and maintain SAS programs for SDTM datasets including aCRF annotation, Pinnacle 21 validation, and reviewer’s guides.
Ensure programming outputs meet project specifications, quality standards, and regulatory requirements.
Perform QC checks, resolve discrepancies, and collaborate with statisticians and cross-functional teams.
Documentation & Compliance
Maintain complete, inspection-ready documentation including SDTM specifications, mock shells, annotated CRFs, and QC reports.
Follow SOPs, Work Instructions, ICH guidelines, and other relevant regulatory standards.
Project Leadership & Mentoring
Act as lead statistical programmer, managing programming deliverables and guiding junior team members.
Participate in sponsor meetings, kick-off meetings, and project reviews as programming representative.
Provide mentorship, develop training materials, and ensure efficient programming workflows.
Collaboration & Communication
Conduct team meetings, track action items, and communicate project status updates effectively.
Collaborate across functional teams to support timely completion of deliverables.
Additional Duties
Handle ad hoc programming requests and other responsibilities as assigned.
Minimal travel may be required.
Qualifications & Experience
Bachelor’s degree in Statistics, Computer Science, Life Sciences, or a related scientific discipline. Equivalent professional experience will also be considered.
Minimum 5 years of clinical SAS programming experience, including end-to-end SDTM dataset development.
Strong expertise in Base SAS and Advanced SAS programming.
Hands-on experience with aCRF annotation, SDTM specifications, Pinnacle 21, and reviewer’s guide development.
Familiarity with Functional Service Organization (FSO) environment is a plus.
Excellent written and verbal communication skills in English.
Proven ability to manage multiple priorities, mentor junior team members, and deliver high-quality outputs in a hybrid work setup.
Why Syneos Health
Work with 94% of Novel FDA-Approved Drugs and 95% of EMA-Authorized Products in recent years.
Join a global network of 29,000 employees across 110 countries, driving innovative clinical solutions.
Thrive in a diverse, inclusive, and career-focused culture with continuous learning, technical training, and growth opportunities.
Learn more: www.syneoshealth.com
Additional Information
The listed responsibilities are not exhaustive. Syneos Health may assign additional duties as required. Equivalent experience, education, or skills will be considered. The company complies with local and global employment regulations, including ADA and the EU Equality Directive, providing reasonable workplace accommodations as appropriate.
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