Job Title: Principal Statistical Programmer
📍 Locations: Available in 3 locations
📂 Category: Clinical
🆔 Job ID: 25189
Summary of Responsibilities
Act as Lead Statistical Programmer on assigned studies.
Plan, execute, and oversee programming activities, including:
Resource estimation and allocation
Budget management
Timeline tracking and delivery
Quality assurance
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 SDTMs, ADaMs, and TFLs.
Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers’ Guides.
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; provide input on complex shells.
Mentor junior programmers on SDTM, ADaM, and TFL processes, ensuring adherence to standards.
Share expertise in departmental meetings and support knowledge transfer.
Respond to QA and client audits; support qualification audits.
Contribute to proposals and bid defense meetings to support business growth.
Continuously recommend improvements in efficiency, quality, and productivity.
Perform other related duties as required.
Qualifications (Minimum Required)
Bachelor’s degree in Mathematics, Statistics, Computing, Life Sciences, Health Sciences, or related field.
Equivalent education and relevant experience may be considered.
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).
Proven experience as Lead Statistical Programmer on complex clinical studies.
Strong understanding of clinical trial processes from start-up to close-out.
Broad knowledge of CDISC requirements (SDTM, ADaM, Define.xml, Reviewer’s Guide, submission standards).
Excellent understanding of related functions, including Biostatistics and Clinical Data Management.
Work Environment & Travel
Work setup: Office-based or home-based (as determined by line manager).
Travel requirements:
Up to 5% travel (local, domestic, regional, global).
May include overnight stays (up to 100% of travel time).
Travel primarily for client meetings and training.
✅ Equal Opportunity: Fortrea is committed to equal employment opportunity and provides accommodations in accordance with applicable laws.
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Canada |Quebec :
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Kyiv |Lima Region :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
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