Senior Statistical Programmer – SDTM Specialist
Location: Hyderabad, India
Job Type: Hybrid
Job ID: 25103419
Updated: December 3, 2025
Syneos Health is a global, fully integrated biopharmaceutical solutions organization that partners with leading pharmaceutical and biotechnology companies to accelerate clinical development. With a workforce of more than 29,000 professionals across 110 countries, Syneos Health delivers data-driven, patient-centric solutions to support modern clinical and commercial needs.
This position offers the opportunity to contribute to high-impact biometrics projects while working with cross-functional global teams.
Position Overview
The Senior Statistical Programmer – SDTM Expert will develop and validate SDTM datasets, create high-quality programming outputs, and support regulatory submissions across multiple clinical studies. The role requires advanced SAS programming expertise, strong SDTM knowledge, and the ability to lead programming activities for assigned studies.
This position is ideal for experienced programmers seeking to expand leadership responsibilities in a global clinical development environment.
Key Responsibilities
Statistical Programming and SDTM Development
Develop custom programming code using SAS or similar tools to generate tables, listings, graphs, and derived datasets aligned with statistical analysis plans.
Perform validation programming and collaborate with statistical programmers, biostatisticians, and study teams to resolve data inconsistencies.
Create and maintain specifications for SDTM datasets and outputs.
Ensure all deliverables meet quality, compliance, and regulatory standards, including ICH guidelines.
Documentation and Compliance
Maintain complete documentation including QC records, test outputs, and programming notes, ensuring readiness for inspections.
Support the preparation and review of statistical analysis plans, mock shells, annotated CRFs, and programming specifications.
Follow SOPs, work instructions, and best practices for statistical programming.
Project and Time Management
Manage timelines across multiple concurrent projects.
Prioritize tasks based on study requirements and adjust workload as needed.
Provide accurate effort estimations for programming activities and ensure timely delivery.
Leadership and Team Collaboration
Act as the lead study programmer, guiding junior programmers and reviewing their work for quality and accuracy.
Conduct internal meetings, distribute documentation, and track action items to completion.
Participate in sponsor discussions, study kickoffs, and bid defense meetings as the programming representative.
Mentor new team members through training sessions and technical guidance.
Additional Responsibilities
Transfer completed deliverables across systems as required.
Support process improvement initiatives within the statistical programming group.
Perform additional tasks as assigned.
Minimal travel may be required.
Required Experience and Qualifications
Education
Bachelor’s degree in statistics, computer science, life sciences, or a related scientific discipline.
Equivalent relevant experience may be considered.
Experience Required
Minimum 5 years of statistical programming experience in the pharmaceutical or clinical trial industry.
Strong, hands-on SDTM expertise across multiple studies.
Proven experience serving as Lead Study Programmer.
Strong proficiency in Base SAS and Advanced SAS.
Experience working within an FSO (Flexible Service Offering) environment is preferred.
Exposure to R programming is an advantage.
Technical and Soft Skills
Strong understanding of clinical trial processes and regulatory submission requirements.
Ability to analyze complex programming challenges, propose solutions, and implement improvements.
Excellent written and verbal communication skills.
Ability to read, write, and communicate clearly in English.
Strong organizational and documentation skills.
About Syneos Health
Syneos Health has supported:
94% of all FDA-approved novel drugs over the past five years
95% of EMA-authorized products
200+ clinical studies across 73,000 sites, involving more than 675,000 trial participants
Employees at Syneos Health work in a dynamic environment that encourages innovation, accountability, and continuous learning.
Additional Information
This job description outlines primary responsibilities but is not exhaustive. Syneos Health may assign additional tasks based on business needs. Equivalent skills and experience may be considered for candidates not meeting every listed requirement. The organization supports equal employment opportunities and complies with all national and international employment regulations.
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