Senior Statistical Programmer (SDTM) – Hybrid | Hyderabad / Gurugram
Location: India – Hyderabad / Gurugram (Hybrid)
Job ID: 25103419
Updated: Today
Syneos Health is a global, fully integrated biopharmaceutical solutions organization committed to accelerating clinical development, regulatory excellence and commercial success. With a presence in more than 110 countries and a team of 29,000 professionals, Syneos Health drives innovation through scientific, clinical, medical affairs and commercial expertise.
This hybrid opportunity is ideal for experienced statistical programmers with deep SDTM knowledge, strong SAS programming capabilities, and the ability to lead study-level programming activities in a dynamic environment.
Position Overview
The Senior Statistical Programmer (SDTM) will develop high-quality statistical deliverables, oversee programming activities, and collaborate closely with Biostatisticians and cross-functional teams. This role requires strong SDTM expertise, proven leadership, and the ability to manage multiple projects in a fast-paced clinical research environment.
Key Responsibilities
Develop and validate SAS programs to generate analysis datasets (SDTM/ADaM), tables, listings, and figures in alignment with statistical analysis plans and sponsor requirements.
Ensure all programming outputs meet quality standards, regulatory guidelines (ICH), and internal SOPs.
Maintain accurate and inspection-ready documentation including testing records, QC outputs, and programming specifications.
Manage timelines across concurrent projects, adapting to priority changes while ensuring timely delivery.
Anticipate programming issues, propose solutions, and support continuous process optimization.
Lead statistical programming activities for assigned studies, guiding junior programmers and reviewing deliverables.
Participate in internal and sponsor meetings, including kick-off and bid-defense presentations.
Provide mentorship, deliver internal training, and help build programming capabilities within the team.
Collaborate effectively with cross-functional partners to resolve data or programming discrepancies.
Perform additional duties as assigned; occasional travel may be required.
Required Experience & Qualifications
Minimum Experience: 5+ years of statistical programming experience in clinical trials, with strong expertise in SDTM.
Proven experience as a Lead Study Programmer.
Bachelor’s degree in statistics, computer science, life sciences, mathematics, or a related scientific discipline (or equivalent experience).
Advanced SAS programming proficiency within pharmaceutical or CRO environments.
Strong understanding of clinical data structures, CDISC standards (SDTM), and regulatory expectations.
Excellent analytical, documentation, verbal, and written communication skills.
Ability to read, write, and communicate effectively in English.
Preferred Qualifications
Experience in an FSP/FSO (Functional Service Provider) model.
Exposure to R programming.
Ability to coordinate across cross-functional teams and manage project-level programming strategies.
Demonstrated capability to handle complex datasets, lead studies, and deliver high-quality outputs.
Why Join Syneos Health
Continuous career development through technical, leadership, and therapeutic training.
Inclusive culture that supports authenticity, collaboration, and professional growth.
Recognition-driven rewards program and strong managerial support.
Exposure to global projects, innovative clinical technologies, and diverse therapeutic areas.
Syneos Health has contributed to 94% of FDA-approved novel drugs, 95% of EMA-authorized products, and over 200 clinical studies in recent years—offering unmatched opportunities for career advancement and skill development.
Learn more at: www.syneoshealth.com
Additional Information
The responsibilities outlined above are not exhaustive and may evolve based on business needs. Equivalent experience or skills will be considered. Syneos Health is committed to equal opportunity employment and adheres to global regulations, including ADA and EU Equality directives.
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