Associate Director, Biostatistics

Bristol Myers Squibb; Uxbridge; On-site; GBP 90,000 - 130,000; Full time

Job summary

Bristol Myers Squibb is seeking an Associate Director of Biostatistics to contribute to trial design, analysis planning and regulatory submissions. The role sits on cross-functional Development teams, with 50% onsite presence in Uxbridge and close collaboration with indication leads and other experts.

The candidate will lead protocol development, SAPs, and CSRs, while guiding teams and communicating results clearly for authorities and publications.

Qualifications

• PhD (6+ years) or MSc (8+ years) in statistics/biostatistics with clinical trials experience.
• Proficiency in SAS, R or Python and advanced statistical analysis.
• Great interpersonal, communication, writing and organizational skills.
• Expertise in statistical/clinical trials methodology applied to development.
• Regulatory understanding and experience with regulatory interactions.

Responsibilities

• Collaborate in the design of innovative clinical trials and study objectives.
• Defend protocols and analysis plans during governance reviews.
• Author or review protocols, SAPs, and clinical study reports.
• Present data and analyses clearly and transparently to stakeholders.
• Provide statistical support for health authority requests and publications.
• Manage multiple studies to ensure consistency and standards.
• Apply broad statistical knowledge to support trial design and development.
• Engage as a matrix team member and act as scientific partner.
• Contribute to external/internal statistical communities of practice.
• Develop and advise team members while adhering to SOPs.

Skills

Communication

Leadership

Project management

Education

PhD in Statistics/Biostatistics

MSc in Statistics/Biostatistics

Tools

SAS

R

Python

Job description

Position Summary

The Associate Director of Biostatistics 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, the Associate Director of Biostatistics can have responsibilities for supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the Biostatistics indication/asset Lead, and other cross functional team members. This role is based in Uxbridge and requires 50% onsite presence.

Key Responsibilities

• Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy
• Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols.
• Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
• Presents summary data and analyses results, in a clear, concise, complete, and transparent manner
• Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information
• Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
• Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development
• Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design.
• Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable
• Contributes to external and internal statistical community of practice
• Develops & advises team members
• Effectively communicates the DQS Mission and Vision in a fashion that generates pride, excitement and commitment within DQS.

Qualifications & Experience

• PhD (6+ years’ experience) or MSc (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience
• Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
• Great interpersonal, communication, writing and organizational skills
• Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework
• Good understanding of regulatory landscape and experience with participating in regulatory interactions
• Demonstrate collaboration, organizational/ leadership abilities, and interpersonal skills
• Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills

Bristol Myers Squibb is Disability Confident – Employer

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.