Associate Director, Biostatistics
At RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, we blend 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. Join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.
About the role
The Associate Director of Biostatistics will guide the design, execution, and interpretation of statistical analyses for clinical trials, facilitating the successful development of innovative radiopharmaceutical therapies. This role requires deep expertise in biostatistical methodologies and the ability to provide strategic guidance throughout the drug development process.
Responsibilities
- Serve as the lead biostatistician for clinical oncology projects, developing and executing statistical strategies, study designs, and analyses.
- Collaborate closely with multidisciplinary project teams to ensure timely communication and alignment of objectives.
- Identify and implement solutions to statistical and data analysis issues related to clinical trials and regulatory submissions.
- Author/own key statistical documents and outputs, including protocol statistical sections, SAPs, and TLF shells.
- Review study-related documents and validate vendor deliverables, including CDISC data specifications and TLF/analysis outputs.
- Work with internal programmers to support regulatory requests, DSUR/IB updates, and ad-hoc analyses as needed.
- Participate in the internal sponsor review of ongoing clinical data.
- Explore and pilot AI initiatives that enhance quality control and operational efficiency.
- Travel approximately 10% of the time; evening and weekend work may be required.
Requirements
- Advanced degree in Statistics or Biostatistics (PhD or MS).
- 6+ years (PhD) or 8+ years (MS) of biostatistics experience in the pharmaceutical/biotech industry.
- Experience utilizing AI-enabled tools to improve productivity and work efficiency.
- Familiarity with statistical programming tools (e.g., SAS and/or R) and working knowledge of CDISC standards (SDTM/ADaM).
- Solid understanding of GCP, ICH guidelines, and regulatory requirements.
- Excellent interpersonal and communication skills, with the ability to influence cross-functional stakeholders.
- Able to function in a highly regulated environment and adhere to all RayzeBio guidelines and SOPs.
Preferred Qualifications
- Prior experience in oncology clinical development.
- Prior experience with global regulatory submissions.
Physical Demands
- Regularly required to sit, reach with hands and arms, and talk or hear.
- Occasionally lift and/or move up to 20 pounds.
- Specific vision abilities required include close and distance vision.
Work Environment
The noise level in the work environment is usually moderate.
Pay
Remote - United States - $189,670 - $229,834 (full-time). Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation will be determined by demonstrated experience.
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support Programs: 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:
- Paid Time Off:
- US Exempt Employees: Flexible time off (unlimited, with manager approval) and 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or RayzeBio).
- 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.
- Additional time off (based on eligibility): 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 Year’s Day.
- Paid Time Off:
Eligibility for benefits may vary based on job and location.