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Principal Biostatistician

8+ years
Not Disclosed
10 Oct. 6, 2025
Job Description
Job Type: Full Time Remote 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

Job ID: 254114
Category: Clinical
Location: Bangalore, India
Work Environment: Office or home-based environment


Role Summary

Lead complex clinical studies, including NDA submissions and multi-protocol programs, providing statistical oversight, project management, and mentorship. Act as a Subject Matter Expert (SME) in statistical analysis and contribute to departmental initiatives and client deliverables.


Primary Responsibilities

  • Lead complex studies, coordinating activities across multiple locations and attending project meetings.

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

  • Serve as DMC Support Statistician: develop DMC Charters and attend DMC Meetings under direction of Statistical Consultants.

  • Lead development of complex Statistical Analysis Plans (SAPs) and review SAPs developed by other statisticians.

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

  • Review TFLs (Tables, Figures, Listings) for complex studies prior to client delivery.

  • Review CRFs and study-specific specifications and plans.

  • Perform complex sample size calculations under supervision.

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

  • Prepare and review randomization specifications and generate randomization schedules.

  • Mentor and train less experienced staff; provide direction and review work of departmental employees.

  • Present knowledge at seminars, team meetings, and external scientific conferences.

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

  • Act as SME: develop or review procedural documents and contribute to new initiatives.

  • Represent the department during audits.

  • Perform all other duties as needed or assigned.


Minimum Required Qualifications

  • Bachelor’s degree (or relevant equivalent experience).

  • Strong communication skills to explain statistical concepts effectively.

  • Knowledge of the overall clinical trial process and its application within Fortrea Clinical Development.

  • Competence in SAP preparation, statistical analysis, and reporting across various trial types.


Minimum Required Experience

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

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


Preferred Qualifications

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


Physical Demands / Work Environment

  • Office or home-based environment.

  • Travel: ~5% of time, with overnight stays up to 100% of travel. Travel primarily for client meetings and trainings.