Senior Statistical Programmer (SDTM) – Hybrid (Hyderabad / Gurugram)
Location: Hyderabad / Gurugram, India (Hybrid)
Job Type: Full-Time
Experience Required: 5+ years
Job ID: 25103411
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. With 29,000 employees across 110 countries, we deliver innovative clinical, medical affairs, and commercial solutions to support modern drug development.
Our Clinical Development model places the patient and customer at the center of every process. By simplifying workflows and enhancing efficiency, we enable faster delivery of therapies while maintaining high-quality standards.
At Syneos Health, we are committed to career development, technical training, and fostering a culture of inclusion, where diverse perspectives drive innovation and collaboration.
Role Overview
We are seeking a Senior Statistical Programmer (SDTM) to join our hybrid team in Hyderabad or Gurugram. The ideal candidate will have extensive experience in clinical programming, SDTM dataset creation, and CDISC standards compliance. You will lead programming for safety and efficacy datasets, manage multiple clinical trials, and mentor junior programmers.
This role requires collaboration with Biostatisticians, Clinical Data Management teams, and project stakeholders to ensure timely and accurate delivery of clinical trial data for regulatory submissions.
Key Responsibilities
Clinical Programming & SDTM Expertise
Develop SDTM datasets, annotated CRFs, SDTM specifications, and e-submission deliverables (DEFINE, SDRG)
Program summary tables, listings, graphs, and derived datasets per Statistical Analysis Plan (SAP) and programming specifications
Perform validation programming, quality checks, and resolve discrepancies with Biostatisticians and project teams
Maintain organized, inspection-ready documentation and programming archives
Project Leadership & Mentoring
Lead programming activities across multiple clinical trials with a minimum of 1+ year lead experience
Review deliverables and provide guidance to junior programmers
Participate in sponsor meetings, study kickoffs, and bid defense presentations as the statistical programming lead
Collaboration & Communication
Work with cross-functional teams including Clinical Data Management, Biostatistics, and Study Leads
Communicate progress, risks, and programming challenges effectively to internal and client stakeholders
Contribute insights and solutions in team discussions and project planning
Compliance & Process Management
Ensure adherence to CDISC SDTM standards, SOPs, Work Instructions, and regulatory guidelines (ICH, FDA, EMA)
Anticipate potential programming challenges, optimize workflows, and improve productivity
Support FSP or full-service projects, ensuring deliverables meet sponsor and regulatory expectations
Qualifications & Experience
Required:
Graduate degree in a scientific or statistical discipline or equivalent professional experience
5+ years of statistical programming experience in clinical trials with SDTM datasets
Hands-on experience with SAS or other statistical programming software
Strong understanding of clinical trial processes, therapeutic areas (Oncology, Neurology, etc.), and CDISC standards
Proven experience leading clinical trial programming projects and mentoring junior team members
Excellent English communication skills (written and verbal)
Preferred:
Experience in Functional Service Provider (FSP) or CRO environments
Exposure across multiple clinical phases (Phase I–IV)
SME-level review and e-submission experience
Why Join Syneos Health
Lead high-impact SDTM programming projects supporting global clinical trials
Work in a collaborative, inclusive, and innovative environment
Mentor junior programmers and contribute to professional development initiatives
Gain exposure to complex clinical trials and regulatory submission processes
Be part of a global organization that values diversity, inclusion, and career growth
SEO & GEO Keywords
Senior Statistical Programmer Hyderabad, SDTM Programmer Gurugram, SAS Clinical Programmer Jobs India, Biostatistics Programming Lead, Clinical Data Management SDTM Careers, Statistical Programming Oncology/Neurology India
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