Principal Statistical Programmer
Locations: Bangalore, Pune, Mumbai, India | Remote (India)
Employment Type: Full-time
Job Requisition ID: 26398
Category: Biostatistics / Statistical Programming
Application Deadline: April 30, 2026
Role Overview
The Principal Statistical Programmer serves as a lead technical expert within clinical research studies, providing end-to-end ownership of statistical programming activities. This role is responsible for overseeing programming deliverables, ensuring regulatory compliance, maintaining high-quality standards, and collaborating closely with Biostatistics, Clinical Data Management, and cross-functional stakeholders.
The position plays a critical role in client interaction, audit readiness, process improvement, and mentorship, contributing directly to the successful execution of complex clinical trials in a global environment.
Key Responsibilities
Act as Lead Statistical Programmer for assigned clinical studies.
Plan, manage, and oversee all statistical programming activities, including resource estimation, budget adherence, timeline management, and quality control.
Develop, validate, and maintain SAS programs to produce SDTM and ADaM datasets and Tables, Figures, and Listings (TFLs).
Perform independent quality control (QC) of SDTM, ADaM, and TFL outputs in compliance with regulatory and internal standards.
Create and maintain Define.xml (XML/PDF), Analysis Results Metadata (ARM), annotated CRFs (aCRFs), and Reviewer’s Guides supporting regulatory submissions.
Lead the development and review of complex SDTM and ADaM specifications and contribute to internal and client programming standards.
Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective and advise on complex TFL development.
Mentor and guide junior and mid-level programmers, ensuring adherence to departmental processes and best practices.
Present technical updates, lessons learned, and best practices at departmental and cross-functional meetings.
Support QA, regulatory, and client audits, including responses to findings and qualification audits.
Contribute to proposal development, bid defenses, and client presentations to support business growth.
Proactively identify and implement process improvements to enhance programming efficiency, quality, and productivity.
Required Qualifications
Bachelor’s degree in Mathematics, Statistics, Computer Science, Life Sciences, Health Sciences, or a related discipline.
Equivalent combination of education and relevant professional experience may be considered in lieu of a formal degree.
Fluency in English (written, reading, and verbal communication).
Required Experience
Minimum 6 years of SAS programming experience within a CRO or pharmaceutical industry environment.
Demonstrated experience serving as a Lead Statistical Programmer on complex clinical studies.
Strong understanding of the end-to-end clinical trial lifecycle, from study start-up through submission and close-out.
In-depth knowledge of CDISC standards, including SDTM, ADaM, Define.xml, Reviewer’s Guides, and regulatory submission requirements.
Proven ability to collaborate effectively with Biostatistics, Clinical Data Management, and other cross-functional teams.
Work Environment
Flexible office-based or remote working model within India, based on business needs and manager approval.
Equal Opportunity Statement
The organization is committed to providing an inclusive workplace and equal employment opportunities. Reasonable accommodations are available throughout the recruitment process.
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