Principal Biostatistician
Location: Bangalore
Category: Clinical
Job ID: 254114
✅ 1. Summary of Responsibilities
A. Study Leadership & Oversight
Lead complex clinical studies including NDA submissions, multi-protocol programs, and multi-site coordination.
Provide statistical oversight and represent statistics in relevant project meetings.
Participate in bid defense meetings to support new business acquisition.
B. Project Management
Manage project timelines, milestones, and resource planning.
Coordinate statistical deliverables across teams and locations.
C. DMC (Data Monitoring Committee) Support
Serve as DMC Support Statistician.
Develop DMC Charters and attend DMC meetings under consultant direction.
D. Statistical Planning & Analysis
Lead development of complex Statistical Analysis Plans (SAPs).
Conduct complex statistical analyses and perform senior reviews of analyses by other statisticians.
Perform advanced sample size calculations.
Provide statistical input to protocols for complex studies.
Conduct overall statistical review of TFLs before client delivery.
E. Study Documentation & Specifications
Review CRFs, study specifications, and statistical requirements.
Prepare and review randomization specifications; generate randomization schedules.
Review and contribute to Clinical Study Reports (CSR) for complex studies.
F. Training, Mentoring & Leadership
Mentor and train junior statisticians.
Review departmental work for accuracy and SOP adherence.
Present and share knowledge at internal seminars and external conferences.
Act as Subject Matter Expert (SME); contribute to procedural documents and new initiatives.
G. Audit & Quality Support
Represent the statistics department during audits.
Ensure high-quality statistical deliverables.
H. Additional Responsibilities
Perform other duties as assigned by management.
✅ 2. Minimum Qualifications
Education
Bachelor’s degree required.
Relevant experience may substitute for formal education.
Experience
8+ years of relevant biostatistics or clinical research experience.
Strong proficiency in SAS® programming, including:
Non-parametric methods
Linear & nonlinear models
Categorical analysis
Survival analysis
Proven ability to communicate statistical concepts clearly.
Solid understanding of the clinical trial process and its application in clinical development.
Experience with:
Statistical Analysis Plans (SAP)
Study analysis & reporting
TFL review
Multi-trial and multi-phase work
✅ 3. Preferred Qualifications
Master’s degree or higher in Biostatistics or related field.
✅ 4. Work Environment & Physical Demands
Office-based or home-based as per line manager decision.
✅ 5. Travel Requirements
Total travel: ~5%
Overnight travel: Up to 100% of travel
Travel primarily for: client meetings & trainings
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