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Principal Statistical Programmer

6+ years
Not Disclosed
10 Sept. 25, 2025
Job Description
Job Type: Full Time 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

📍 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.