Senior Manager, Biostatistics
Location: Hyderabad, Telangana, India
Job ID: R1601626
Company: Bristol Myers Squibb
Role Summary
The Senior Manager, Biostatistics is a key member of cross-functional clinical development teams responsible for providing statistical expertise throughout the clinical trial lifecycle. The role contributes to study design, protocol development, statistical analysis planning, data interpretation, clinical study reporting, and regulatory submissions. The position requires strong technical, analytical, and communication skills to support evidence-based decision-making across drug development programs.
Key Responsibilities
Clinical Trial Design & Statistical Strategy
Collaborate with cross-functional teams in the design and planning of clinical studies.
Provide statistical input on study methodology, endpoints, sample size determination, and analysis strategies.
Support development of scientifically robust and regulatory-compliant clinical trial designs.
Contribute to decision-making throughout the clinical development process.
Statistical Analysis & Data Interpretation
Perform and/or validate statistical analyses for clinical trial data.
Interpret study results and provide statistical insights to support clinical and regulatory decisions.
Recommend effective methods for data visualization and presentation.
Ensure analyses are scientifically sound, accurate, and aligned with study objectives.
Study Documentation & Regulatory Support
Author and review:
Protocol Synopses
Clinical Trial Protocols
Statistical Analysis Plans (SAPs)
Case Report Forms (CRFs)
Clinical Study Reports (CSRs)
Publications and Manuscripts
Study-Level Specification Documents
Support preparation of regulatory submission packages and health authority interactions.
Ensure compliance with regulatory requirements and industry standards.
Cross-Functional Collaboration
Partner with Clinical Development, Medical Affairs, Data Management, Programming, Regulatory Affairs, and other stakeholders.
Communicate statistical concepts to both technical and non-technical audiences.
Translate scientific and clinical questions into statistical methodologies.
Present study findings and analytical outcomes to project teams and leadership.
Quality & Compliance
Ensure adherence to company SOPs, policies, and quality standards.
Maintain compliance with global regulatory requirements and industry guidelines.
Support consistency and standardization across studies and therapeutic areas.
Take responsibility for the quality and accuracy of statistical deliverables.
Scientific & Technical Development
Stay current with emerging statistical methodologies and industry best practices.
Apply advanced statistical techniques where appropriate.
Expand knowledge of drug development, clinical research, regulatory expectations, and commercial considerations.
Contribute to innovation and continuous improvement initiatives.
Mentorship & Leadership
Mentor and support junior statisticians and team members.
Provide technical guidance and knowledge sharing.
Promote collaboration, inclusiveness, and professional development within the team.
Foster a culture of scientific excellence, innovation, and continuous learning.
Required Qualifications
Education
PhD in Statistics, Biostatistics, Mathematics, Data Science, Epidemiology, or related quantitative discipline
OR
Master's Degree in Statistics, Biostatistics, Mathematics, Data Science, Epidemiology, or related quantitative discipline
Experience
PhD with 3+ years of experience
OR
Master's Degree with 5+ years of experience
Experience in:
Clinical Trials
Drug Development
Pharmaceutical Industry
Biotechnology Industry
Healthcare Research
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