Senior Statistical Programmer (SDTM) – Hyderabad / Gurugram (Hybrid)
Location: Hyderabad / Gurugram, India (Hybrid)
Job Type: Full-Time
Experience Required: 5+ Years
Job ID: 25103411
Updated: Yesterday
About Syneos Health
Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, commercial expertise, and advanced statistical programming capabilities, we deliver innovative solutions that improve healthcare outcomes worldwide.
With more than 29,000 employees across 110 countries, Syneos Health fosters a collaborative, inclusive, and innovation-driven culture where every role contributes to advancing patient-centric solutions.
Position Overview
Syneos Health is seeking an experienced Senior Statistical Programmer (SDTM) to join our hybrid teams in Hyderabad or Gurugram. This role is responsible for leading SDTM programming activities, delivering high-quality outputs, and providing subject-matter expertise in clinical trial data management, CDISC standards, and statistical programming across multiple therapeutic areas.
The Senior Statistical Programmer will work closely with cross-functional clinical teams, data managers, and biostatisticians to ensure regulatory-compliant datasets, quality deliverables, and efficient project execution.
Key Responsibilities
Lead SDTM programming for multiple clinical trials, including CRF annotations, SDTM specification creation, and data management tasks.
Handle safety and efficacy datasets, vendor data, and e-submission deliverables, including DEFINE.XML and SDRG generation.
Develop SAS or other statistical programming code to produce analysis datasets, tables, listings, and figures per statistical analysis plans and project specifications.
Perform validation programming, identify discrepancies, and collaborate with cross-functional teams to resolve findings.
Maintain accurate and up-to-date project documentation, including QC and testing records, ensuring inspection readiness.
Manage project priorities, timelines, and deliverables across multiple studies, adapting workloads as necessary.
Participate in internal and sponsor meetings, contributing ideas and reporting on project status.
Provide mentorship and guidance to junior programmers, develop training materials, and support skill development.
Review statistical documentation, including SAPs, mock shells, programming specifications, and annotated CRFs, providing feedback to improve efficiency and accuracy.
Apply strong problem-solving skills to address complex programming challenges.
Minimal travel may be required.
Required Qualifications
Graduate degree in a scientific, statistical, or related discipline; equivalent combination of education and programming experience considered.
5+ years of experience in statistical programming with strong exposure to SDTM standards.
Subject-matter expertise in clinical domains, including oncology, neurology, or other therapeutic areas.
Hands-on experience across clinical phases (Phase I–IV), with proven project leadership for 1+ year.
Proficiency in SAS and other required statistical software; familiarity with advanced CDISC standards preferred.
Excellent communication, teamwork, and problem-solving skills.
Experience in Functional Service Organization (FSO) models preferred.
Strong understanding of clinical trial data management and regulatory compliance standards (ICH/GCP).
Why Join Syneos Health
Contribute to clinical studies that have supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Work in a collaborative, inclusive, and innovative environment with global exposure.
Access opportunities for professional growth, mentorship, and skill enhancement.
Competitive compensation and benefits package.
Additional Information
This job description highlights the primary responsibilities of the role. Syneos Health reserves the right to modify duties as business needs evolve. The company is an equal opportunity employer and complies with all applicable employment and accessibility laws. Reasonable accommodations will be provided as required.
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