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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: Apache Spark, Artificial Intelligence (AI), Big Data, Data Governance, Data Literacy, Data Management, Data Quality, Data Science, Data Strategies, Data Visualization, Machine Learning (ML), Master Da, Auditing, Audit Management, Audits Compliance, Communication, Continued Learning, Decision Making, Gmp Procedures, Inspection Readiness, Managing Ambiguity, Organizing, People Management and Leadershi, Bachelor’s Degree (BS) or Master’s Degree (MS) in: Life Sciences Pharmacy Biotechnology Biomedical Sciences Chemistry Regulatory Affairs Or related scientific disciplines, Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Causality Assessment, Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences, Clinical Research, Clinical Trials, Curious Mindset, Databases, Drug Development, Job Description, Lifesciences, Medical Communication, Medical Information, Medical Writing, Military Intelligence, Pat, Clinical SAS Programming, Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, 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