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Principal Statistical Programmer

6 years
Not Disclosed
10 Sept. 15, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ 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: Lead Statistical Programmer

Location: [Specify Location]
Work Environment: Office or remote (as requested by line manager)
Travel Requirements: Up to 5% travel; may require overnight stays for client meetings and trainings


Summary of Responsibilities

The Lead Statistical Programmer will plan, execute, and oversee all programming activities for clinical studies, ensuring high-quality deliverables while managing resources and timelines. Responsibilities include:

  • Programming & Data Management:

    • Develop and maintain SAS programs for SDTM and ADaM datasets, TFLs, and associated QC activities.

    • Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs (aCRFs), and Reviewers Guides to support SDTMs and ADaMs.

    • Develop or lead development of complex SDTM and ADaM specifications, contributing to Fortrea and client standards.

  • Leadership & Mentorship:

    • Lead programming efforts on complex studies, including resource estimation, budget management, and timeline adherence.

    • Mentor junior programmers on SDTM, ADaM, and TFL processes to ensure compliance with departmental standards.

    • Present knowledge and insights during department meetings.

  • Collaboration & Review:

    • Review SAPs and TFL shells from a programming perspective, advising on complex TFL development.

    • Collaborate with Biostatistics, Clinical Data Management, and other departments to ensure smooth study execution.

  • Quality & Compliance:

    • Respond to QA and client audits, supporting qualification audits as needed.

    • Identify and implement process improvements to enhance efficiency, quality, and productivity.

  • Business Development Support:

    • Contribute to proposal preparation and participate in bid defense meetings to support business growth.

  • Other Duties:

    • Perform additional tasks as needed or assigned.


Qualifications

  • Education:

    • Bachelor’s degree in Mathematics, Statistics, Computing, Life Sciences, Health Sciences, or related field.

    • Relevant work experience may be considered in lieu of formal education.

  • Language Skills:

    • English (speaking, reading, and writing) required.


Experience

  • Minimum of 6 years of SAS® programming experience in CROs or Pharmaceutical industry.

  • Proven experience as Lead Statistical Programmer on complex clinical studies.

  • Strong knowledge of all clinical trial phases and related disciplines (Biostatistics, Clinical Data Management).

  • Comprehensive understanding of CDISC standards (SDTM, ADaM, define.xml, Reviewers Guide, submission standards).


Physical Demands & Work Environment

  • Work can be office-based or remote.

  • Travel required: local, domestic, regional, and global (approx. 5% of time; overnight stays possible).


EEO & Accommodations

Fortrea is committed to equal employment opportunities and provides reasonable accommodations upon request.