Job Title: Principal Biostatistician
Location: Bangalore
Category: Clinical / Biostatistics
Job ID: 254114
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.
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.
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.
Master’s degree or higher in Biostatistics or related field.
Experience preparing SAPs, analyzing complex trials, and reporting clinical data.
Office or home-based work environment as required.
Approximately 5% travel, primarily for client meetings and trainings (may include overnight stays).
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