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Principal Biostatistician

8+ years
Not Disclosed
10 July 31, 2025
Job Description
Job Type: Full Time 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

 

Principal Biostatistician – Clinical Research (Bangalore)

Location: Bangalore, India
Work Mode: Hybrid (Office or Remote as per manager approval)
Category: Clinical Biostatistics
Experience Level: 8+ Years
Job Type: Full-Time


Job Summary

Fortrea is actively hiring an experienced Principal Biostatistician to lead complex statistical efforts for regulatory submissions, multi-protocol trials, and strategic clinical programs. This is a key role supporting NDA submissions, DMC charters, Statistical Analysis Plans (SAP), and cross-functional collaborations for global studies. Ideal for biostatistics experts with strong SAS skills and a deep understanding of the clinical trial lifecycle.


Key Responsibilities

  • Lead complex studies and NDA submissions across multiple geographies

  • Develop and review Statistical Analysis Plans (SAPs)

  • Perform and validate complex statistical analyses using SAS

  • Prepare randomization schedules and review CRFs

  • Support DMCs by developing charters and attending meetings

  • Conduct statistical review of Tables, Listings, and Figures (TFLs)

  • Supervise and mentor junior statisticians

  • Attend bid defense meetings for complex clinical programs

  • Present at internal seminars and external scientific forums

  • Serve as SME on procedural improvements and departmental audits


Required Skills & Qualifications

  • Bachelor’s degree in Biostatistics, Statistics, or related field (Master’s preferred)

  • Minimum 8 years of experience in statistical programming or clinical biostatistics

  • Advanced proficiency in SAS (including non-parametric, survival analysis, linear models)

  • Demonstrated expertise in SAPs, randomization, and CSR contributions

  • Knowledge of global clinical trial processes and regulatory standards

  • Excellent verbal and written communication skills

  • Strong project management and mentoring abilities


Preferred Skills

  • Master’s degree or PhD in Biostatistics or a related field

  • Experience with NDA submissions and global regulatory requirements

  • Exposure to multiprotocol or large-scale clinical trial programs


Perks & Benefits

  • Flexible hybrid work model (office/home-based)

  • International exposure to complex clinical programs

  • Collaborative, research-driven culture

  • Travel opportunities (~5%) to client meetings or training sessions

  • Competitive compensation and growth opportunities


Company Description

Fortrea is a globally recognized Contract Research Organization (CRO) delivering world-class clinical development and biostatistical solutions. With operations in over 100 countries and deep experience across 20+ therapeutic areas, Fortrea partners with leading pharmaceutical, biotech, and medical device companies to advance life-changing therapies.


Work Mode

Hybrid – Office or remote work based on managerial discretion.


Call to Action

Are you ready to elevate your biostatistics career in global clinical development? Apply now to become a Principal Biostatistician at Fortrea and make a measurable impact in transforming healthcare.