Director, Biostatistics

Bristol Myers Squibb•Princeton, NJ
•$218,740 - $296,867•Onsite

About The Position

Bristol Myers Squibb is a purpose-driven company focused on discovering, developing, and delivering innovative medicines to combat serious diseases. They offer meaningful work, growth opportunities, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This role contributes to the development of compounds within a therapeutic area, driving the design of innovative and efficient clinical trials, including population and endpoint selection. The position involves developing trial designs to support regulatory approval and market access, contributing to Clinical Development Plans, submissions, and post-submission strategies. The role also includes 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, developing 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.
  • Complies with BMS processes and SOPs, adheres 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 the 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 fashion that generates pride, excitement, and commitment within GBDS.
  • 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, carries out performance reviews and feedback, and develops performance metrics for staff.

Benefits

  • Wellbeing support
  • Retirement and financial protection benefits
  • Insurance offerings (medical, dental, vision, life and disability)
  • Flexible Time Off (FTO) for U.S.-based exempt employees
  • 11 paid company holidays each year
  • 160 hours of paid vacation annually for new hires (non-exempt employees, RayzeBio employees, and employees located in Puerto Rico)
  • 3 optional holidays
  • Paid sick leave
  • Up to two paid volunteer days per year
  • Summer hours flexibility
  • Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
  • Annual Global Shutdown between Christmas Day and New Year's Day
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