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Manager, Biostatistics

Bristol Myers Squibb
2+ years
Not Disclosed
Hyderabad
10 June 9, 2026
Job Description
Job Type: Full Time, Hybrid 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, Medical Coding, Medical Terminology, mRS and EQ-5D-5L, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager, Biostatistics
Job ID: R1601602
Company:
Bristol Myers Squibb
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Function: Global Biometrics / Biostatistics (Clinical Development)


Position Summary

The Manager, Biostatistics contributes to clinical trial design, statistical planning, analysis, and interpretation of study data across global development programs. The role supports cross-functional teams in generating high-quality evidence for regulatory submissions, publications, and clinical decision-making.


Key Responsibilities

Clinical Trial Design & Analysis

  • Contribute to clinical trial design aligned with study objectives and hypotheses

  • Develop or review statistical sections of:

    • Protocols

    • Statistical Analysis Plans (SAPs)

    • Data Presentation Plans

  • Perform or support statistical analyses (pre-planned and ad hoc)

  • Validate statistical outputs and ensure methodological accuracy


Study Support & Reporting

  • Support preparation of:

    • Clinical Study Reports (CSRs)

    • Regulatory submission documents

    • Scientific publications

  • Present and interpret statistical results to cross-functional teams

  • Translate scientific questions into statistical frameworks and vice versa


Cross-Functional Collaboration

  • Work closely with Biostatistics Lead and global study teams

  • Collaborate with Clinical Development, Programming, Data Management, and Regulatory teams

  • Provide statistical input for protocol amendments and study decisions

  • Participate in team discussions and decision-making processes


Regulatory & Quality Compliance

  • Ensure compliance with:

    • BMS SOPs

    • Global regulatory requirements

    • Study-level standards

  • Maintain high quality standards in statistical deliverables

  • Support inspection and audit readiness when required


Technical & Methodological Work

  • Apply statistical methodologies in clinical trial design and analysis

  • Conduct data manipulation, simulation, and graphical analysis

  • Use statistical programming tools for analysis and validation

  • Contribute to methodological improvements within teams


Minimum Qualifications

Education

  • MS in Statistics / Biostatistics or related field
    OR

  • PhD in Statistics (fresh graduates with relevant coursework/internships considered)


Experience

  • 1–2 years of clinical trial or pharmaceutical industry experience preferred

  • Fresh PhD candidates with strong statistical background acceptable


Key Skills & Competencies

Technical Skills

  • Statistical programming: SAS / R / Python

  • Clinical trial design & analysis understanding

  • Data manipulation, visualization, and simulation

  • Knowledge of regulatory statistics in drug development


Core Competencies

  • Strong analytical and problem-solving ability

  • Scientific thinking and statistical reasoning

  • Ability to interpret and communicate complex results

  • Attention to detail and quality focus


Soft Skills

  • Strong communication (written & verbal)

  • Collaboration in cross-functional teams

  • Ability to manage multiple priorities

  • Openness to feedback and continuous learning


Role Focus Areas

  • Clinical Trial Statistics

  • Regulatory Biostatistics Support

  • Study Design & Protocol Development

  • Statistical Programming & Analysis

  • Global Clinical Development Collaboration