Director, Biostatistics

Bristol Myers Squibb•Madison, WI

About The Position

The Director of Biostatistics is a member of cross-functional teams and contributes to the development of compounds within a therapeutic area. The role drives the design of innovative and efficient clinical trials, including selection of study populations and endpoints, and develops trial designs that address study objectives and support regulatory approval and market access. The Director contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defenses, and provides statistical leadership and guidance to statisticians to ensure high-quality, timely deliverables. The role also manages resources, sets priorities, and ensures consistency and adherence to standards. The Director serves as a scientific and strategic partner in drug development, engaging with development teams, BMS governance, key stakeholders, and external regulatory bodies. The role provides leadership on statistical submissions and health authority interactions, supports publications and presentations, contributes to departmental SOPs and statistical training, and represents BMS in professional societies and industry discussions. It also includes coaching, mentoring, and developing team members, contributing to workforce planning and talent management, and managing functional or project budgets and resource allocation.

Requirements

  • PhD with 9 or more years of experience, or MS with 11 or more years of experience, in statistics, biostatistics, or a related scientific field, with experience in clinical trials, drug development, the pharmaceutical industry, or healthcare.
  • Proficiency in scientific computing and programming with SAS, R, or Python, and in advanced statistical analysis, data manipulation, graphing, and simulation.
  • Excellent interpersonal, communication, writing, and organizational skills.
  • Expertise applying general and cutting-edge statistical and clinical-trial methodology to complex statistical problems in clinical development, aligned with regulatory agency and industry standards.
  • Experience preparing for and participating in interactions with global regulatory agencies.
  • Demonstrated collaboration, organizational and leadership abilities, and interpersonal skills.
  • Demonstrated development of approaches to enhance workforce planning and talent management for internal and external talent pools within a therapeutic area.

Nice To Haves

  • At least 3 years of direct or matrix management experience is preferred for people-manager positions.

Responsibilities

  • Drive innovative and efficient clinical study design, including selection of populations and endpoints.
  • Develop study designs that address objectives and support regulatory approval, medical research, and market access.
  • Independently lead, initiate, and oversee statistical support for compound development within a therapeutic area.
  • Provide guidance and management to statisticians to ensure high-quality, timely deliverables.
  • Engage as a scientific and strategic partner on high-level cross-functional development teams.
  • Present and defend complex statistical solutions to BMS governance, stakeholders, and external regulatory bodies to inform decisions.
  • Contribute to Clinical Development Plans; lead GBDS-related submission activities and post-submission strategies, preparations, and defenses.
  • Provide statistical support and leadership for health authority requests, publications, presentations, and other public releases of information.
  • Comply with BMS processes and SOPs, follow global and project standards, and ensure deliverable quality.
  • Contribute to the creation and maintenance of departmental SOPs and provide training on statistical topics.
  • Manage functional or project budgets, allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards.
  • Represent BMS at professional societies and industry-wide technical discussions, and contribute to the statistical community of practice.
  • Coach biostatistical team members as they develop solutions to problems.
  • Communicate the GBDS Mission and Vision to foster pride, excitement, and commitment within GBDS.
  • Act as an employee advocate and management coach or mentor to team members internally and externally.
  • Empower and develop the team; guide employee development plans, conduct performance reviews and provide feedback, and develop staff performance metrics.
  • Develop approaches to enhance workforce planning and talent management for internal and external talent pools within a therapeutic area.

Benefits

  • Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance.
  • Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
  • Paid company holidays: 11 annually.
  • Eligible employees may receive paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leave for medical, personal, parental, caregiver, bereavement, or military needs.
  • Eligible employees may participate in an annual Global Shutdown between Christmas Day and New Year's Day.
  • Non-exempt employees, RayzeBio employees, and employees in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, as well as 11 paid company holidays and 3 optional holidays.
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