Senior Manager – Biostatistics
Location: Gurugram / Mumbai, India (Hybrid)
Department: Biostatistics & Biometrics
Job Grade: Senior Manager
Company: Sun Pharmaceutical Industries Ltd.
Employment Type: Full-Time
Job Summary
The Senior Manager – Biostatistics is responsible for providing strategic and operational statistical leadership across clinical development programs, registration studies, and global regulatory submissions. The role supports the design, execution, analysis, interpretation, and reporting of clinical trials from Phase I through Phase IV while ensuring compliance with regulatory requirements and industry standards.
The incumbent will collaborate closely with Clinical Development, Medical Affairs, Statistical Programming, Data Management, Regulatory Affairs, Pharmacovigilance, and external partners to deliver high-quality statistical analyses that support critical business and regulatory decisions.
Reporting to the Senior Director – Biostatistics, the role serves as a key contributor to study design, statistical methodology, regulatory interactions, and innovation initiatives within the Biostatistics function.
Key Responsibilities
Statistical Leadership & Clinical Development Support
Serve as the Lead Biostatistician for assigned clinical development programs and multiple clinical studies.
Provide statistical expertise throughout the clinical trial lifecycle.
Support study design, protocol development, endpoint selection, and analysis strategy development.
Ensure statistical methodologies align with clinical, scientific, and regulatory objectives.
Collaborate with cross-functional teams to support development and registration strategies.
Statistical Analysis Planning
Author and review:
Statistical Analysis Plans (SAPs)
Table, Listing, and Figure (TLF) Shells
Randomization Specifications
Statistical Sections of Study Protocols
Statistical Reports and Supporting Documentation
Ensure consistency between study protocols, SAPs, and regulatory requirements.
Data Analysis & Reporting
Plan and oversee statistical analyses for clinical studies.
Review and approve:
Analysis Data Model (ADaM) Specifications
Statistical Programming Deliverables
TLF Outputs
Clinical Data Analysis Reports
Ensure statistical outputs meet quality standards and regulatory expectations.
Interpret study results and provide scientific recommendations to project teams.
Regulatory Submission Support
Support global regulatory submissions, including:
NDA (New Drug Applications)
BLA (Biologics License Applications)
Supplemental Regulatory Filings
Provide statistical input for:
Clinical Study Reports (CSRs)
Regulatory Briefing Documents
Health Authority Responses
Submission Packages
Participate in regulatory interactions and support responses to agency queries.
Advanced Statistical Methodology
Apply advanced statistical techniques to support drug development programs.
Design and evaluate:
Bayesian Statistical Models
Adaptive Clinical Trial Designs
Sample Size Determination
Power Calculations
Simulation-Based Trial Assessments
Evaluate innovative methodologies to improve study efficiency and decision-making.
Exploratory Analysis & Scientific Support
Conduct exploratory analyses to support scientific and clinical decision-making.
Provide statistical consultation to cross-functional teams.
Support publication activities, including:
Scientific Manuscripts
Medical Conference Presentations
Posters
Abstracts
Contribute to evidence generation and scientific communication initiatives.
Cross-Functional Collaboration
Collaborate closely with:
Clinical Development
Medical Affairs
Statistical Programming
Clinical Data Management
Regulatory Affairs
Pharmacovigilance
Clinical Operations
External CROs and Vendors
Participate in study team and project governance meetings.
Provide statistical guidance and recommendations to stakeholders.
Ensure alignment between statistical strategy and overall development objectives.
Innovation & Continuous Improvement
Contribute to development and implementation of innovative statistical methodologies.
Support process optimization and operational excellence initiatives.
Participate in:
SOP Development
Statistical Standards Development
Best Practice Implementation
Training Programs
Drive continuous improvement within the Biostatistics function.
Quality & Compliance
Ensure compliance with:
ICH Guidelines
Good Clinical Practice (GCP)
Regulatory Requirements
Internal SOPs
Industry Standards
Maintain audit and inspection readiness.
Ensure statistical deliverables meet quality and compliance expectations.
Educational Qualifications
Required
PhD in:
Biostatistics
Statistics
Mathematics
Epidemiology
Related Quantitative Discipline
Alternative Qualification
Master’s Degree in:
Biostatistics
Statistics
Mathematics
Epidemiology
Related Quantitative Discipline
with significant industry experience.
Experience Requirements
Required
PhD with a minimum of 5 years of relevant pharmaceutical, biotechnology, or CRO experience.
OR
Master’s Degree with a minimum of 10 years of relevant pharmaceutical, biotechnology, or CRO experience.
Preferred
Experience supporting global clinical development programs.
Experience across Phase I–IV clinical trials.
Experience supporting regulatory submissions.
Experience in multidisciplinary clinical development environments
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