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.
Job Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
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.
Skills and Knowledge:
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.
Basic Requirements:
Advanced degree in Statistics or Biostatistics
12+ years of biostatistics experience in pharmaceutical/biotech industry
Prior oncology experience
Preferred Requirements:
PhD
Radiopharmaceutical experience
Physical demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment:
The noise level in the work environment is usually moderate.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
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.
RayzeBio and Bristol Myers Squibb
RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
Supporting People with Disabilities
BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.
R1599731 : Senior Director, Biostatistics