Principal Biostatistician
📍 Location: Bangalore
🏢 Category: Clinical
🆔 Job ID: 254114
Job Overview
The Principal Biostatistician provides statistical leadership for complex studies, including NDA submissions and multi-protocol programs. This role involves statistical oversight, project management, mentoring, and contributing to study design, analysis, and reporting, ensuring high-quality deliverables and regulatory compliance.
Key Responsibilities
Statistical Leadership & Analysis
Lead complex studies and multi-location programs, providing statistical oversight.
Perform senior review of Statistical Analysis Plans (SAPs) developed by other statisticians.
Conduct complex statistical analyses and quality checks of analyses by other staff.
Perform overall statistical review of TFLs (Tables, Figures, Listings) prior to client delivery.
Review CRFs and study-specific specifications and plans.
Perform complex sample size calculations under supervision of senior statistical staff.
Develop statistical sections of protocols and review Clinical Study Reports (CSRs).
Prepare and review randomization specifications and generate randomization schedules.
Project Management
Plan and manage project resources, timelines, and milestones for assigned studies.
Support DMC (Data Monitoring Committee) activities, including developing DMC Charters and attending DMC meetings.
Represent the department during audits.
Mentoring & Knowledge Sharing
Mentor and train less experienced staff; review work to ensure accuracy and compliance with departmental policies.
Present knowledge at internal seminars, team meetings, and external scientific conferences.
Participate in bid defense meetings for complex studies to support business development.
Act as Subject Matter Expert for procedural documents and new initiatives.
Other Duties
Perform additional duties as assigned by management.
Qualifications
Education
Minimum: Bachelor’s degree (Fortrea may consider relevant experience in lieu of formal education).
Preferred: Master’s degree or higher in Biostatistics or related field.
Experience
Minimum: 8+ years of relevant experience or equivalent combination of education and experience.
Proficiency in SAS® programming and statistical procedures including non-parametric analysis, linear/non-linear models, categorical data, and survival analysis.
Strong knowledge of clinical trial processes and their application in clinical development.
Competence in preparing SAPs, performing analyses, and reporting results across a variety of trials.
Skills
Proven ability to effectively communicate statistical concepts.
Strong mentoring, project management, and organizational skills.
Physical Demands & Work Environment
Office or home-based environment as directed by the line manager.
Travel: ~5% of time; overnight travel may be required up to 100% of that time. Travel primarily to client meetings and trainings.
Equal Opportunity
Fortrea is an Equal Opportunity Employer. Learn more about EEO & Accommodations here.
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