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Senior Manager, Biostatistics

Bristol Myers Squibb
0-2 years
24-38 lakh
Hyderabad
10 June 15, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Position Summary

The Senior Manager – Biostatistics is a key member of cross-functional drug development teams responsible for clinical trial design, statistical analysis planning, data interpretation, regulatory submissions, and scientific reporting. The role requires collaboration with Biostatistics Leads and multiple functional teams to ensure high-quality statistical support throughout the clinical development lifecycle.


Key Responsibilities

Clinical Trial Design & Development

  • Collaborate in the design of clinical studies.

  • Contribute to study methodology, statistical analysis, and interpretation of results.

  • Support evidence generation for clinical development programs.

Protocol & Statistical Documentation

  • Author and review:

    • Protocol Synopses

    • Clinical Trial Protocols

    • Statistical Analysis Plans (SAPs)

    • Case Report Forms (CRFs)

    • Clinical Study Reports (CSRs)

    • Publications and study-level documents

Statistical Analysis & Reporting

  • Perform and validate statistical analyses.

  • Recommend effective methods for data visualization and presentation.

  • Ensure clarity and accuracy of statistical outputs.

Data Interpretation & Communication

  • Present findings to cross-functional teams.

  • Interpret clinical trial data for study reports and publications.

  • Translate complex scientific concepts into understandable statistical insights.

Regulatory & Quality Compliance

  • Ensure compliance with:

    • Company SOPs

    • Global standards

    • Regulatory requirements

    • Clinical development guidelines

  • Maintain high-quality statistical deliverables.

Team Development & Leadership

  • Guide and mentor junior team members.

  • Share statistical expertise and best practices.

  • Support a collaborative and inclusive team culture.

Continuous Learning

  • Enhance knowledge of:

    • Advanced statistical methodologies

    • Drug development processes

    • Regulatory requirements

    • Commercial and clinical considerations


Required Qualifications

Education

  • PhD in Statistics/Biostatistics (Fresh PhD candidates may be considered)

OR

  • MS in Statistics/Biostatistics with 2+ years of relevant experience


Required Experience

  • Clinical Trials

  • Pharmaceutical Industry

  • Drug Development

  • Healthcare Research

  • Biostatistics and Data Analysis


Technical Skills

Programming Languages

  • SAS

  • R

  • Python

Statistical Expertise

  • Advanced Statistical Analysis

  • Clinical Trial Data Analysis

  • Data Manipulation

  • Statistical Modeling

  • Simulations

  • Graphing & Visualization


Preferred Qualifications

  • Experience with advanced statistical methods.

  • Understanding of regulatory requirements.

  • Knowledge of clinical trial design and interpretation.

  • Experience supporting regulatory submissions.


Key Competencies

  • Statistical Thinking

  • Scientific Communication

  • Analytical Problem Solving

  • Cross-Functional Collaboration

  • Project Management

  • Leadership & Mentoring

  • Attention to Detail

  • Regulatory Compliance

Potential Total Compensation:

  • Fixed Salary

  • Annual Performance Bonus (10–20%)

  • Long-Term Incentives (role dependent)

  • Health & Wellness Benefits

  • Retirement Benefits

  • Learning & Development Programs


Work Model

Hybrid (Site-by-Design)

  • Minimum 50% onsite presence required.

  • Remaining days may be worked remotely as per company policy.


Ideal Candidate Profile

A professional with strong expertise in Biostatistics, Clinical Trial Design, and Statistical Programming (SAS/R/Python) who can independently contribute to clinical development programs, support regulatory submissions, mentor team members, and communicate complex statistical findings to cross-functional stakeholders within a global pharmaceutical environment.


Career Progression

Senior Manager – BiostatisticsAssociate Director, BiostatisticsDirector, BiostatisticsSenior Director / Therapeutic Area HeadExecutive Leadership Roles in Clinical Development & Data Sciences.