Principal Statistical Programmer (SDTM) – Hyderabad / Gurugram (Hybrid)
Updated: December 5, 2025
Location: Hyderabad / Gurugram, India (Hybrid)
Job ID: 25103392
Category: Statistical Programming | Clinical Data Management
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical, medical, and commercial success. With operations across 110 countries and more than 29,000 employees, we deliver data-driven clinical development models that place both customers and patients at the center.
We are seeking an experienced Principal Statistical Programmer (SDTM) to lead advanced statistical programming activities across global clinical studies. This hybrid role is available in Hyderabad or Gurugram, India.
Role Overview
The Principal Statistical Programmer will take ownership of SDTM programming strategy, delivery, quality, and compliance across complex and multi-study clinical programs. The role involves technical leadership, cross-functional collaboration, regulatory compliance, and mentorship of programming teams. Candidates must demonstrate expertise in SDTM, CDISC standards, and regulatory submission requirements.
Key Responsibilities
Statistical Programming & SDTM Development
Develop, validate, and maintain complex SAS programs to generate SDTM datasets, tables, listings, graphs, and derived datasets in alignment with SAP and programming specifications.
Lead end-to-end SDTM activities including CRF annotation, SDTM specifications, dataset creation, Pinnacle 21 validation, SDRG preparation, and submission packages.
Ensure all deliverables comply with quality standards, project timelines, SOPs, WIs, and ICH regulatory guidelines.
Quality, Documentation & Compliance
Maintain complete, organized, and inspection-ready documentation including test scripts, QC documents, define.xml files, and submission standards.
Drive issue identification, resolution, and cross-functional alignment on programming discrepancies.
Conduct CDISC compliance reviews for SDTM/ADaM deliverables and submission-ready datasets.
Leadership & Collaboration
Serve as Lead Programmer, supervising programming activities and ensuring timely delivery across concurrent projects.
Participate in kick-off meetings, sponsor discussions, and bid defense meetings as the statistical programming representative.
Mentor junior programmers by developing training content, reviewing deliverables, and providing structured feedback.
Technical Expertise & Process Improvement
Act as subject matter expert in CDISC, SDTM, ADaM, and regulatory submission standards.
Provide strategic input into SAS/automation tools, macros, and standardization efforts to increase programming efficiency.
Contribute to the development of SOPs, guidelines, and operational workflows for the Biometrics division.
Project & Stakeholder Management
Establish realistic programming timelines, negotiate expectations with internal stakeholders, and proactively communicate project risks.
Lead internal meetings, track action items, and maintain clear documentation to support cross-functional operations.
Additional Duties
Handle tasks assigned by management as required.
Minimal travel may be necessary.
Required Qualifications & Experience
Bachelor’s degree in Statistics, Computer Science, Life Sciences, or a related discipline. Equivalent experience may be considered.
Minimum 8 years of Clinical SAS Programming experience, including extensive SDTM programming exposure.
Strong expertise in Base SAS and Advanced SAS.
Proven experience in:
End-to-end SDTM development
CRF annotation
SDTM/ADaM specification generation
Dataset creation and validation
Pinnacle 21 and submission-package preparation
SDRG development
Experience working with Trial Design datasets.
Exposure to R programming is preferred.
Experience leading global or complex studies with distributed programming teams.
Strong working knowledge of CDISC Standards and regulatory submission expectations.
Prior mentorship experience in CDISC and statistical programming processes.
Excellent written and verbal communication skills in English.
FSO (Functional Service Organization) experience is an advantage.
Why Join Syneos Health
Worked with 94% of Novel FDA-Approved Drugs and 95% of EMA-Authorized Products in the past 5 years.
Opportunity to contribute to over 200 studies across 73,000 sites globally.
A diverse, inclusive work culture with structured career development, technical training, and global exposure.
A dynamic environment designed to accelerate clinical and operational excellence.
Learn more at syneoshealth.com
Additional Information
The duties listed in this job description are not exhaustive. Syneos Health may assign additional responsibilities as needed. The company adheres to all employment regulations, including ADA and the EU Equality Directive, and provides reasonable accommodations for applicants and employees. This job description does not constitute an employment contract.
Role Summary
The Principal Statistical Programmer leads the development, validation, and delivery of SDTM datasets and statistical programming outputs for regulatory submission. This role requires deep programming expertise, mastery of CDISC standards, strategic project leadership, and cross-functional collaboration to support data-driven clinical development initiatives.
Gujarat :
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