Senior Manager, Biostatistics

Bristol Myers Squibb; Denham; On-site; GBP 90,000 - 125,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Manager, Biostatistics to contribute to trial design, analysis planning and regulatory submissions. You will collaborate with GBDS Biostatistics Lead, clinicians and regulatory teams to deliver high-quality statistical deliverables.

The role emphasizes cross-functional teamwork, methodological excellence, and proactive communication to support global filings and product development across indications.

Qualifications

• Significant academic training in statistics/biostatistics.
• Experience in pharmaceutical/drug development is required.
• Ability to work within cross-functional teams and support global filings.

Responsibilities

• Contribute to development strategy for safe and effective product use.
• Design innovative, efficient clinical trials with appropriate populations and endpoints.
• Translate scientific questions into statistical terms for analyses.
• Ensure hypotheses are clearly articulated and data support analyses.
• Communicate results effectively with clinical and regulatory partners.
• Build external reputation through collaborations and conferences.
• Prepare study documents: protocol synopsis, SAP, CRFs, reports.
• Ensure quality and adherence to SOPs and project standards.

Skills

Cross-functional collaboration

Verbal & written communication

Organization & prioritization

Education

PhD in statistics/biostatistics or MSc with experience

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us.

Position Summary

The biostatistician is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, biostatisticians can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBDS Biostatistics Lead, GBDS medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.

Key Responsibilities

• Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product.
• Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
• Translates scientific questions into statistical terms and statistical concepts into lay terms.
• Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis.
• Communicates effectively with clinical and regulatory partners and external opinion leaders.
• Builds the external reputation of BMS via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation.
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents.
• Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted.
• Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of statistical deliverables, e.g., tables, listings, and figures.
• Takes accountability for ensuring quality in all planning, design and execution of the assigned protocol or project.
• Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles.
• Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
• Drives alignment at team level and escalates lack of team alignment to the GBDS Lead for resolution.
• Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions.
• Keeps up to date with state-of-the art applied statistical methodology

Qualifications & Experience

• Significant academic training in statistics, biostatistics or relevant areas of study. PhD degree in statistics or biostatistics or Master's degree with relevant experience required.
• > 3 years Pharmaceutical/Drug Development or other related experience
• Understanding of the application of biostatistics to medical/clinical trials data.
• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals.
• Excellent verbal and written communications skills.
• Ability to organize multiple work assignments and establish priorities.
• This position may require up to 20% domestic and/or international business travel

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role. Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1603886 Senior Manager, Biostatistics