Associate Director, Biostatistics

Bristol Myers Squibb • Princeton, NJ

18h

About The Position

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, this role may support a particular indication of an asset. The Associate Director develops collaborative relationships and works effectively with the Biostatistics indication/asset Lead and other cross-functional team members.

The role applies extensive knowledge of statistical and clinical-trial methodology to clinical development, while building knowledge of the clinical, regulatory, and commercial environments and applying it to study design. It also provides scientific and strategic partnership in drug development, ensures work complies with company processes and standards, and contributes to the statistical community of practice. For people-manager positions, the role also includes team leadership, coaching, and performance-management responsibilities.

Requirements

• PhD with 6 or more years of experience, or MS with 8 or more years of experience, in statistics, biostatistics, or a related scientific field.
• Experience in clinical trials, drug development, the pharmaceutical industry, or healthcare.
• Proficiency in scientific computing/programming using SAS, R, or Python.
• Ability to implement advanced statistical analyses, data manipulation, graphing, and simulation.
• Expertise in statistical and clinical-trial methodology as it relates to clinical development, and ability to apply it within the relevant clinical-development framework.
• Good understanding of the regulatory landscape and experience participating in regulatory interactions.
• Strong interpersonal, communication, writing, and organizational skills.
• Demonstrated collaboration, organizational and leadership abilities, and interpersonal skills.
• Ability to plan, organize, and prioritize multiple work assignments, with strong project-management skills.

Nice To Haves

• People-manager experience (for people-manager positions only).

Responsibilities

• Collaborate on the design of innovative and efficient clinical trials, including selection of study populations and endpoints, and contribute to project development strategy.
• Defend protocols and analysis plans at internal governance reviews and independently review complex protocols.
• Independently author and/or review protocols, statistical analysis plans, clinical study reports, publications, and other study-level documents.
• Present summary data and analysis results clearly, concisely, completely, and transparently.
• Provide statistical support and leadership for health authority requests, publications, presentations, and other public releases of information.
• Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area.
• Apply statistical and clinical-trial methodology to clinical development.
• Develop knowledge of clinical, regulatory, and commercial environments and apply it to study design.
• Engage effectively as a matrix team member and scientific and strategic partner on project teams in the drug-development process.
• Comply with BMS processes and SOPs, adhere to global and project standards, and ensure the quality of deliverables.
• Contribute to the external and internal statistical community of practice.
• Develop and advise team members.
• Effectively communicate the DQS Mission and Vision in a way that generates pride, excitement, and commitment within DQS.
• For people-manager positions, act as an employee advocate and management coach or mentor; empower and develop the team; guide employee development plans; conduct performance reviews and provide feedback; and develop staff performance metrics.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation, paid company holidays, and optional holidays for certain employee groups, subject to eligibility and applicable terms.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree