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Principal Biostatistician

8+ years
Not Disclosed
10 Sept. 12, 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 / Biostatistics
Job ID: 254114


Job Overview

The Principal Biostatistician leads complex clinical studies, providing statistical oversight across multi-protocol programs and coordinating activities across multiple locations. This role combines statistical expertise, project management, and mentoring responsibilities to ensure high-quality statistical deliverables for clinical trials.


Key Responsibilities

Statistical Leadership & Oversight

  • Lead complex studies including NDA submissions and multi-protocol programs.

  • Provide statistical oversight and senior review of statistical analysis plans (SAPs) developed by other statisticians.

  • Conduct complex statistical analyses and quality check analyses performed by other team members.

  • Perform overall statistical review of Tables, Figures, and Listings (TFLs) prior to client delivery.

  • Develop statistical sections of protocols for complex studies.

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

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

  • Prepare and review randomization specifications and generate randomization schedules.

  • Serve as DMC Support Statistician, including development of DMC Charters and attendance at DMC meetings.

Project Management

  • Plan resources, timelines, and milestones for assigned projects.

  • Attend project meetings to coordinate activities and ensure timely delivery of statistical outputs.

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

Mentorship & Training

  • Provide guidance, training, and mentorship to junior statisticians and departmental staff.

  • Review work of departmental employees to ensure accuracy and adherence to policies, practices, and procedures.

Regulatory & Documentation

  • Contribute to clinical study reports (CSRs) and regulatory submissions.

  • Act as Subject Matter Expert (SME) for procedural documents and new initiatives.

  • Represent the department during audits and external meetings.

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


Minimum Qualifications

  • Bachelor’s degree in Biostatistics, Mathematics, or related field (relevant experience may substitute).

  • 8+ years of experience in biostatistics or clinical research.

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

  • Strong understanding of the clinical trial process and its application in clinical development.

  • Excellent communication skills to explain statistical concepts effectively.


Preferred Qualifications

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

  • Experience preparing SAPs, analyzing complex trials, and reporting clinical data.


Work Environment & Travel

  • Office or home-based work environment as required.

  • Approximately 5% travel, primarily for client meetings and trainings (may include overnight stays).