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 leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a global presence across 110 countries and over 29,000 employees, we leverage clinical, medical affairs, and commercial expertise to deliver innovative solutions in drug development and commercialization. Our Clinical Development model places patients and customers at the center, ensuring efficient, high-quality, and compliant clinical trial outcomes.
We foster a culture of inclusion, career development, and continuous learning, providing technical and therapeutic area training, mentorship, and recognition programs for employees to thrive in a dynamic, collaborative environment.
Role Overview
We are seeking a Senior Statistical Programmer (SDTM) with strong expertise in clinical programming for safety and efficacy datasets. This hybrid role requires leadership of multiple clinical trials, hands-on SDTM programming, and proficiency in CDISC standards across diverse therapeutic areas including Oncology, Neurology, and others.
As a senior contributor, you will design, develop, and validate statistical datasets, tables, listings, and graphs using SAS or other statistical programming tools, ensuring regulatory compliance and high-quality deliverables. This role also involves mentoring junior programmers, coordinating with cross-functional teams, and supporting client interactions for study delivery and programming strategies.
Key Responsibilities
Statistical Programming & Data Management
Develop SDTM datasets, annotated CRFs, SDTM specifications, and e-submission deliverables (DEFINE, SDRG)
Create tables, listings, graphs, and derived datasets according to Statistical Analysis Plans (SAPs) and programming specifications
Perform validation programming, quality control, and discrepancy resolution with Biostatisticians and project teams
Maintain well-organized, inspection-ready project documentation
Project Leadership & Mentoring
Lead programming activities for multiple clinical trials and ensure timelines, quality, and regulatory compliance
Review programming deliverables, provide technical feedback, and guide junior programmers
Participate in sponsor meetings, bid defenses, and study kickoffs as the statistical programming representative
Collaboration & Communication
Work closely with cross-functional teams including Clinical Data Management, Biostatistics, and Study Leads
Effectively communicate programming progress, issues, and resolutions to internal and client stakeholders
Prepare for meetings, contribute insights, and provide solutions to potential programming challenges
Process & Compliance
Ensure adherence to CDISC standards, SOPs, Work Instructions, and applicable regulatory guidelines (ICH, FDA, EMA)
Anticipate and address potential programming issues to streamline workflow and improve productivity
Maintain up-to-date knowledge of therapeutic areas, clinical trial processes, and programming best practices
Qualifications & Experience
Required:
Graduate degree in a scientific or statistical discipline, or equivalent professional experience
5+ years of statistical programming experience in clinical trials, including SDTM, ADaM, and safety/efficacy datasets
Hands-on experience with SAS or other statistical programming software
Strong knowledge of CDISC standards, SDTM implementation, clinical data management, and regulatory submission requirements
Proven experience in leading clinical trial programming projects and mentoring junior programmers
Excellent written and verbal communication skills in English
Preferred:
Experience in Functional Service Provider (FSP) or contract research organization (CRO) settings
Exposure to multiple clinical phases (Phase I–IV)
Knowledge across therapeutic areas such as Oncology, Neurology, or other specialized fields
Why Join Syneos Health
Lead high-impact statistical programming projects supporting global clinical trials
Work in a collaborative and inclusive environment with opportunities for mentorship and career progression
Gain exposure to complex, multi-therapeutic clinical trials and regulatory submissions
Be part of a global organization that values innovation, diversity, and professional growth
SEO & GEO Keywords
Senior Statistical Programmer Hyderabad, SDTM Programmer Gurugram, Clinical SAS Programmer Jobs India, Biostatistics Programming Lead, CDISC SDTM Programming Careers, Clinical Data Management Programming India
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