Senior Director, Biostatistics

Bristol Myers SquibbSan Diego, CA
1d$261,110 - $316,404

About The Position

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ RayzeBio is seeking an experienced and visionary Senior Director of Biostatistics to lead theranostic (imaging and therapeutic) development within the Biometrics department. This position requires not only deep expertise in biostatistical methodologies but also the ability to provide strategic vision, regulatory leadership, and cross-functional influence throughout the drug development process. The Senior Director will mentor and grow the internal statistics team, strengthen statistical processes and SOPs, and ensure RayzeBio remains submission and inspection-ready as its pipeline expands.

Requirements

  • Proven track record of leadership, mentoring, and team development.
  • Demonstrated expertise in innovative trial designs and complex statistical methodologies, with Bayesian methods experience highly preferred.
  • Ability to balance strategic leadership with hands-on execution of statistical analyses and deliverables.
  • Excellent interpersonal and communication skills, with the ability to influence cross-functional stakeholders.
  • Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).
  • Solid understanding of GCP, ICH guidelines, and regulatory requirements.
  • Advanced degree in Statistics or Biostatistics
  • 12+ years of biostatistics experience in pharmaceutical/biotech industry
  • Prior oncology experience

Nice To Haves

  • PhD
  • Radiopharmaceutical experience

Responsibilities

  • Lead end-to-end statistical strategy for clinical programs from early-phase through NDA/MAA submissions and product launch.
  • Provide statistical leadership for regulatory interactions, including FDA/EMA meetings, Advisory Committees, inspection readiness, and submission
  • Design and implement innovative trial methodologies to accelerate clinical development while ensuring statistical rigor and regulatory alignment.
  • Collaborate with cross-functional teams to drive development decisions and integrate statistical perspectives into program strategies.
  • Oversee biostatistics deliverables, including protocol development, SAPs, TFLs, and CSRs, ensuring accuracy, quality, and timely completion.
  • Partner with internal programming and data management teams to support regulatory requests, publications, safety updates, and exploratory analyses.
  • Participate in and lead internal sponsor reviews of ongoing trial data, providing clear statistical insights for decision-making.
  • Oversee resource allocation and budget planning for biostatistics activities across assigned programs.
  • Build and mentor a high-performing project team, provide coaching and career development to direct reports.
  • Develop and establish SOPs and best practices within biostatistics and programming.
  • Willing to travel approximately 10% of the time.
  • Evening and weekend work will be involved.

Benefits

  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 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.
  • Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
  • Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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What This Job Offers

Job Type

Full-time

Career Level

Director

Education Level

Ph.D. or professional degree

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