Job Title: Principal Statistical Programmer
Job ID: 25189
Category: Clinical
Locations: Available in 3 locations
Work Environment: Office or home-based, as requested by the line manager
Travel Requirements: Yes – local, domestic, regional, global (~5% of time; overnight stays up to 100% of travel)
Role Summary
Lead statistical programming activities for clinical studies, ensuring high-quality SDTM and ADaM datasets, TFLs, and supporting documentation. Mentor junior programmers, contribute to standard development, and participate in client-facing and internal quality initiatives.
Primary Responsibilities
Serve as Lead Statistical Programmer on studies.
Plan, execute, and oversee all programming activities, including:
Resource estimation
Budget adherence
Meeting timelines
Quality assurance
Interdepartmental and client interactions
Develop and maintain SAS programs for SDTM and ADaM datasets and TFLs.
Perform QC on SDTM, ADaM datasets, and TFLs.
Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers’ Guides.
Develop and review complex specifications for SDTM and ADaM datasets; contribute to Fortrea and client standards.
Review SAPs and TFL shells; advise on complex TFL development.
Mentor less-experienced programmers on SDTM, ADaM, and TFL processes.
Present knowledge in department meetings.
Support QA and client audits, including qualification audits.
Contribute to proposals and participate in bid defense meetings.
Identify and suggest improvements in efficiency, quality, and productivity of statistical programming.
Perform additional duties as assigned.
Minimum Required Qualifications
Bachelor’s degree (preferred: mathematics, statistics, computing, life science, health science, or related subjects).
Relevant experience may be considered in lieu of educational requirements.
English language proficiency in speaking, reading, and writing.
Minimum Required Experience
Typically, 6 years of SAS® programming experience in CRO or pharmaceutical industry (or equivalent combination of education and experience).
Experience as lead statistical programmer on complex clinical studies.
Broad knowledge of clinical trials from setup to completion, including Biostatistics and Clinical Data Management roles.
Comprehensive understanding of CDISC standards for SDTM and ADaM, including define.xml, Reviewers’ Guide, and submission standards.
Physical Demands
Extensive computer-based work.
Office or home-based environment.
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