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.
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