Job Summary
Fortrea, a globally recognized Contract Research Organization (CRO), is seeking a Principal Statistical Programmer to join its Bangalore team. This role offers a unique opportunity to lead programming activities for complex clinical studies, ensuring quality deliverables across SDTM, ADaM datasets, and TFLs. Ideal for candidates with over 6 years of SAS® programming experience in the CRO or pharmaceutical industry, this position is critical in supporting clinical trial data processing, analysis, and regulatory submissions.
Key Responsibilities
Serve as Lead Statistical Programmer on complex clinical research studies.
Plan, execute, and oversee all programming activities while ensuring adherence to budget, timeline, and quality standards.
Develop and maintain SAS® programs to produce SDTM, ADaM datasets, and TFLs; perform quality control (QC) on these outputs.
Generate Define XML/PDFs, Analysis Results Metadata (ARM), Annotated CRFs, and Reviewers Guides.
Create and review complex specifications for SDTM and ADaM datasets and contribute to internal and client-specific standards development.
Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective.
Mentor junior programmers on statistical programming processes and industry best practices.
Represent programming function in client meetings and proposal activities, including bid defenses.
Identify opportunities to improve programming efficiency, productivity, and quality.
Support internal QA and client audits as required.
Required Skills & Qualifications
Bachelor’s degree in mathematics, statistics, computing, life sciences, health sciences, or related fields.
Minimum of 6 years of SAS® programming experience in CRO or pharmaceutical industry.
Demonstrated leadership as a statistical programmer on complex studies.
Comprehensive knowledge of clinical trial processes from set-up to completion.
Expertise in CDISC standards including SDTM, ADaM, define.xml, and regulatory submission guidelines.
Strong understanding of Biostatistics and Clinical Data Management functions.
Perks & Benefits
Opportunity to lead global clinical trial programming projects.
Exposure to innovative clinical development technologies and platforms.
Flexible work environment (office or home-based as per manager's discretion).
Travel opportunities for client meetings and training (approx. 5% travel requirement).
Career development and learning programs in a supportive global organization.
Company Description
Fortrea is a leading global Contract Research Organization (CRO) that provides clinical development and technology solutions to pharmaceutical, biotechnology, and medical device companies. Operating in over 100 countries, Fortrea transforms drug and device development across 20+ therapeutic areas.
Work Mode
Hybrid (Office or Home-based as per management discretion)
Call-to-Action
Ready to advance your career as a Principal Statistical Programmer in a global CRO? Apply now to be part of Fortrea’s transformative clinical research team.
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