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Principal Biostatistician

8+ 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

Principal Biostatistician

Location: Bangalore
Category: Clinical
Job ID: 254114


Summary of Responsibilities

(Not exhaustive; may include other duties as assigned)

  • Lead complex studies such as NDA submissions or multi-protocol programs, coordinating activities across multiple locations, providing statistical oversight, and attending project meetings.

  • Manage projects: resource planning, timelines, and milestone tracking.

  • Serve as DMC Support Statistician by developing DMC Charters and attending DMC meetings under Statistical Consultant direction.

  • Lead the development of complex Statistical Analysis Plans (SAPs) and provide senior review of SAPs prepared by other statisticians.

  • Perform complex statistical analyses and quality check analyses produced by other statisticians.

  • Conduct overall statistical review of TFLs (Tables, Figures, Listings) for complex studies prior to client delivery.

  • Review CRFs and other study-specific specifications and plans.

  • Perform complex sample size calculations under senior statistical staff supervision.

  • Develop statistical sections of protocols for complex studies under Statistical Consultant supervision.

  • Provide statistical input and review for Clinical Study Reports (CSRs).

  • Prepare and review randomization specifications; generate randomization schedules.

  • Mentor and train junior staff, providing oversight, direction, and review to ensure accuracy and compliance.

  • Present and share knowledge internally (seminars, team meetings) and externally (scientific meetings, conferences).

  • Participate in bid defense meetings for complex studies (e.g., NDA submissions) to support new business opportunities.

  • Act as Subject Matter Expert (SME) in developing/reviewing procedural documents or leading new initiatives.

  • Represent the department during audits.


Qualifications (Minimum Required)

  • Bachelor’s degree in a relevant field.

  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.


Experience (Minimum Required)

  • 8+ years’ experience, or an equivalent combination of education and experience, to successfully perform key responsibilities.

  • Proficiency in SAS® programming and statistical procedures (e.g., non-parametric analysis, linear and non-linear models, categorical data, survival analysis).

  • Strong ability to communicate statistical concepts effectively.

  • Solid understanding of the clinical trial process and its application in Fortrea Clinical Development.

  • Proven competence in preparation of SAPs, statistical analyses, and reporting across diverse trials.


Preferred Qualifications

  • Master’s degree or higher in Biostatistics or a related field.


Work Environment / Physical Demands

  • Office or home-based environment, as directed by the line manager.

  • Travel requirements:

    • Approximately 5% of time.

    • Of this, up to 100% may require overnight stays.

    • Travel primarily for client meetings and trainings.