Principal Statistical Programmer (SDTM) – Hybrid
Location: Hyderabad / Gurugram, India (Hybrid)
Employment Type: Full-Time
Job ID: 25103395
Last Updated: December 10, 2025
Job Overview
Syneos Health is seeking an experienced Principal Statistical Programmer (SDTM) to join its global Clinical Development and Biometrics team. This role is ideal for senior-level statistical programming professionals with deep expertise in SAS programming, CDISC SDTM standards, and regulatory submissions, who can lead complex global clinical trial deliverables in a hybrid work environment.
As a Principal Statistical Programmer, you will act as a technical leader, ensuring high-quality, compliant statistical programming outputs while mentoring teams and partnering closely with Biostatistics, Clinical Operations, and Sponsors.
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization dedicated to accelerating the delivery of therapies that improve lives. With operations across 110+ countries and involvement in the majority of recent FDA- and EMA-approved drugs, Syneos Health combines clinical development, medical affairs, and commercial expertise to drive meaningful outcomes.
Key Responsibilities
Lead end-to-end statistical programming activities using SAS to produce SDTM datasets, tables, listings, figures (TLFs), and derived datasets as per SAPs and programming specifications
Serve as Lead Statistical Programmer, directing and reviewing work of other programmers across multiple concurrent studies
Develop and review complex dataset and output specifications aligned with sponsor and regulatory requirements
Perform validation programming and resolve discrepancies in collaboration with programmers and biostatisticians
Ensure full compliance with CDISC standards (SDTM, ADaM), ICH guidelines, SOPs, and regulatory submission requirements
Conduct peer reviews of SAPs, annotated CRFs, mock shells, DEFINE.XML, and programming documentation
Maintain inspection-ready documentation, QC records, and version-controlled programming deliverables
Participate in sponsor meetings, study kickoffs, bid defenses, and internal governance forums as a programming representative
Mentor and train statistical programming staff; contribute to capability building and knowledge sharing initiatives
Support development and standardization of macros, tools, and programming efficiencies
Act as a CDISC Subject Matter Expert, providing guidance, training, and compliance reviews
Proactively manage timelines, risks, and deliverable status, ensuring on-time, high-quality outputs
Stay current with clinical development practices, regulatory expectations, and evolving industry standards
Required Qualifications & Experience
Bachelor’s degree in Statistics, Mathematics, Life Sciences, Computer Science, or a related discipline
(Equivalent combination of education and relevant experience will be considered)
8–12+ years of hands-on statistical programming experience in a clinical trial or CRO/pharma environment
Advanced proficiency in SAS programming for clinical data
Strong expertise in CDISC standards, particularly SDTM (ADaM experience preferred)
Proven experience supporting regulatory submissions to FDA, EMA, or other global agencies
Demonstrated ability to lead global or complex programming projects
Prior experience mentoring or managing junior programmers
Excellent written and verbal communication skills in English
Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment
Work Model & Location
Hybrid work model
Primary locations: Hyderabad or Gurugram, India
Minimal travel may be required based on project needs
Why Join Syneos Health
Opportunity to work on global, high-impact clinical development programs
Strong career development, training, and progression pathways
Inclusive, diverse, and people-first work culture
Exposure to cutting-edge clinical research and regulatory submissions
Competitive compensation and total rewards program
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and is committed to providing an inclusive and accessible work environment. Reasonable accommodations will be provided for qualified individuals with disabilities in accordance with applicable laws.
Apply now on ThePharmaDaily.com to advance your career in clinical statistical programming with a global biopharmaceutical leader.
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Frank Scottile Blvd |Missouri :
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Niš |Bohemia :
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