Job Title: Principal Statistical Programmer
📍 Locations: Available in 3 locations
📂 Category: Clinical
🆔 Job ID: 25189
Summary of Responsibilities
Serve as Lead Statistical Programmer for assigned studies.
Plan, execute, and oversee all programming activities, including:
Resource estimation and allocation
Budget management
Timeline adherence
Quality maximization
Cross-functional and client interactions
Develop and maintain SAS® programs to generate:
SDTM and ADaM datasets
Tables, Listings, and Figures (TFLs)
Perform QC checks of SDTM, ADaMs, and TFLs.
Produce Define XML/PDFs, ARM, annotated CRFs, and Reviewers’ Guides to support SDTMs and ADaMs.
Lead the development of complex SDTM and ADaM specifications and contribute to Fortrea and client standards.
Review SAPs and TFL shells from a programming perspective; advise on complex TFL shells.
Mentor junior programmers on SDTM, ADaM, and TFL processes while ensuring compliance with departmental standards.
Share expertise by presenting at departmental meetings.
Support QA and client audits as well as qualification audits.
Contribute to proposals and bid defense meetings to support new business opportunities.
Continuously identify and recommend efficiency, quality, and productivity improvements in statistical programming.
Perform additional tasks as assigned.
Qualifications – Minimum Required
Bachelor’s degree (preferred in Mathematics, Statistics, Computing, Life Science, Health Science, or related fields).
Equivalent education and relevant work experience may be considered in lieu of a degree.
Language Requirements:
Speaking: English (required)
Reading/Writing: English (required)
Experience – Minimum Required
6+ years of SAS® programming experience in the CRO or Pharmaceutical industry (or equivalent combination of education and experience).
Proven experience as Lead Statistical Programmer on complex clinical studies.
Strong knowledge of clinical trials across all phases, including roles of Biostatistics and Clinical Data Management.
Comprehensive knowledge of CDISC standards (SDTM, ADaM, Define.xml, Reviewer’s Guide, submission requirements).
Work Environment & Travel
Flexible: Office-based or home-based, depending on line manager’s request.
Travel Requirements:
Up to 5% travel, including local, domestic, regional, and global.
May require overnight stays (up to 100% of travel time).
Travel primarily for client meetings and training sessions.
✅ Equal Opportunity: Fortrea is committed to workplace equity and provides accommodations in accordance with applicable laws.
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