Director, Biostatistics

Bristol Myers Squibb • Princeton, NJ

2d • $218,740 - $265,060 • Hybrid

About The Position

The Director of Biostatistics is a key member of a cross-functional team, contributing to the development of compounds within a specific therapeutic area. This role drives the design of innovative and efficient clinical trials, including the selection of study populations and endpoints. The Director develops trial designs that address study objectives to support regulatory approval and market access. They also contribute to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defenses. A significant part of the role involves providing guidance and management to statisticians to ensure high-quality and timely deliverables, managing resources, setting priorities, and ensuring adherence to standards.

Requirements

• PhD (9+ years experience) or MS (11+ 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.
• Excellent interpersonal, communication, writing and organizational skills.
• Demonstrate expertise in applying knowledge of general and cutting-edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.
• Experience in preparing and participating in global regulatory agency interactions.
• Demonstrate excellent collaboration, organizational/leadership abilities, and interpersonal skills.
• Demonstrate development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area.
• At least 3 years management (direct or matrix) experience is preferred (for people manager position only).

Responsibilities

• Drives innovative and efficient study design.
• Develops study designs that address study objectives to support regulatory approval, medical research, and market access.
• Independently leads, initiates, and oversees the statistical support for the development of compounds within a therapeutic area.
• Provides guidance and management to statisticians to ensure high-quality and timely deliverables.
• Effectively engages as a matrix team member on high-level development teams, acting as a scientific and strategic partner in the drug development process.
• Presents and defends complex statistical solutions to all levels of BMS governance, key stakeholders, and external regulatory bodies in a clear, concise, complete, and transparent manner that influences key decisions.
• Contributes to Clinical Development Plans, leads GBDS related submission activities, and post-submission strategies/preparations/defenses.
• Provides statistical support and leadership to address health authority requests, publications, presentations, and other public releases of information.
• Ensures compliance with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area, and is responsible for the quality of deliverables.
• Contributes to the creation/maintenance of and provides training on statistical topics and departmental SOPs.
• Manages a functional or project budget and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards.
• Represents BMS at professional societies and in industry-wide technical discussions.
• Contributes to the statistical community of practice.
• Provides active coaching to biostatistical team members when developing solutions to problems.
• Effectively communicates the GBDS Mission and Vision in a way that generates pride, excitement, and commitment within GBDS.
• Enables a culture of inclusiveness, respect for diversity, compliance with process, and allows for questioning and challenging others in a respectful and constructive manner.
• Effectively engages as an employee advocate and management coach/mentor to team members both internally and externally.
• Provides leadership to empower and develop the team.
• Provides guidance to employee development plans and carries out performance reviews and feedback.
• Develops performance metrics for staff.

Benefits

• Medical, pharmacy, dental, and vision care.
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Flexible time off (unlimited, with manager approval) for US Exempt Employees.
• 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
• Unlimited paid sick time (based on eligibility).
• Up to 2 paid volunteer days per year (based on eligibility).
• Summer hours flexibility (based on eligibility).
• Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
• Annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Director