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Principal Statistical Programmer

Fortrea
Fortrea
0-2 years
Not Disclosed
10 April 10, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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
Location: Bangalore,Mumbai & Pune
Category: Clinical
Job ID: 2444693


Summary of Responsibilities:

  • Act as the Lead Statistical Programmer on assigned studies.

  • Plan, execute, and oversee all programming tasks related to a study:

    • Estimate resources, manage budgets, meet deadlines, ensure high quality.

    • Collaborate across departments and with clients.

  • Develop and maintain SAS programs to generate:

    • Complete SDTM and ADaM datasets.

    • Tables, Figures, and Listings (TFLs).

    • Perform quality control (QC) for SDTMs, ADaMs, and TFLs.

  • Create submission documents:

    • Define XML/PDFs, Analysis Results Metadata (ARM), Annotated CRFs (aCRFs), and Reviewers’ Guides.

  • Lead development of complex specifications for SDTM and ADaM datasets.

  • Contribute to Fortrea and client data standards.

  • Review Statistical Analysis Plans (SAPs) and TFL shells; advise on complex TFL development.

  • Mentor junior programmers on best practices for SDTM, ADaM, and TFL development.

  • Share expertise during departmental meetings.

  • Support internal and client audits, including QA and qualification audits.

  • Participate in proposal development and bid defense meetings.

  • Identify and recommend improvements in efficiency, quality, and productivity within statistical programming.

  • Perform other duties as assigned.