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Principal Biostatistician

8+ years
Not Disclosed
10 Sept. 30, 2025
Job Description
Job Type: Full Time Hybrid 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 Biostatistician

📍 Location: Bangalore
🏢 Category: Clinical
🆔 Job ID: 254114


Job Overview

Lead complex clinical studies, including NDA submissions and multi-protocol programs. Provide statistical oversight, project management, mentoring, and quality review of analyses, TFLs, and reports. Represent the department in audits and contribute to new business initiatives.


Key Responsibilities

📊 Statistical Leadership

  • Lead complex studies across multiple locations, providing statistical oversight.

  • Develop and review complex Statistical Analysis Plans (SAPs).

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

  • Conduct overall statistical review of TFLs prior to client delivery.

  • Develop statistical sections of protocols and provide statistical input for Clinical Study Reports (CSRs).

  • Prepare and review randomization specifications and generate randomization schedules.

🗂️ Project Management

  • Perform project management activities including resource planning, timelines, and milestone management.

  • Serve as DMC Support Statistician, developing DMC charters and attending DMC meetings.

  • Represent department during audits.

  • Attend bid defense meetings for complex studies to support business growth.

👥 Mentorship & Training

  • Mentor and train less experienced staff.

  • Provide direction and review work of departmental employees to ensure accuracy and adherence to policies and procedures.

  • Present and share knowledge in team meetings, seminars, and external conferences.

📝 Documentation & Compliance

  • Act as Subject Matter Expert (SME) on procedural documents or new initiatives.

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


Minimum Qualifications

🎓 Education:

  • Bachelor’s degree or equivalent experience.

Fortrea may consider relevant and equivalent experience in lieu of formal education.

💼 Experience:

  • 8+ years of experience, or equivalent combination of education and experience.

  • Ability to program in one or more statistical software packages (SAS®).

  • SAS proficiency, including non-parametric analysis, linear/non-linear models, categorical data, and survival analysis.

  • Good knowledge of the overall clinical trial process.

  • Competence in preparation of SAPs, analyses, and reporting across a variety of trials.

🗣️ Skills & Competencies:

  • Proven ability to effectively communicate statistical concepts.


Preferred Qualifications

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


Physical Demands / Work Environment

  • Office or home-based environment as requested by line manager.

  • Travel: ~5% of time, potentially including overnight stays for client meetings or trainings.


Equal Opportunity & Accommodation

Fortrea is an Equal Opportunity Employer committed to providing reasonable accommodations to qualified individuals.

📎 Learn more about EEO & Accommodations [here].