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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

  • 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.