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Principal Statistical Programmer

6+ years
Not Disclosed
10 Oct. 6, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.