Associate Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the principal biostatistician for clinical oncology projects, crafting and executing statistical strategies, study designs, and analyses.

• Partner with multidisciplinary project teams to ensure effective communication and alignment of goals.

• Recognize and implement solutions for statistical and data analysis challenges related to clinical trials and regulatory submissions.

• Author and take ownership of critical statistical documents and outputs, such as protocol statistical sections, SAPs, and TLF shells.

• Review study-related documents and validate vendor deliverables, including CDISC data specifications and TLF/analysis outputs.

• Collaborate with internal programmers to support regulatory requests, DSUR/IB updates, and ad-hoc analyses.

• Engage in internal sponsor reviews of ongoing clinical data.

• Investigate and pilot AI initiatives that enhance quality control and operational efficiency.

• Travel around 10% of the time.

• Occasionally work evenings and weekends.

⛳️ Requirements

• Advanced degree in Statistics or Biostatistics (PhD or MS).

• 8+ years of biostatistics experience in the pharmaceutical/biotech sector with a PhD, or 10+ years with an MS.

• Experience with AI-enabled tools to enhance productivity and work efficiency.

• Proficiency in statistical programming tools such as SAS and/or R.

• Familiarity with CDISC standards (SDTM/ADaM).

• Capability to review and interpret key statistical outputs.

• Ability to manage vendors and ensure quality, timeliness, and compliance of biometrics deliverables.

• Strong understanding of GCP, ICH guidelines, and regulatory requirements.

• Excellent interpersonal and communication abilities, with the capacity to influence cross-functional stakeholders.

• Competence to operate in a highly regulated environment and adhere to RayzeBio guidelines and SOPs.

• Prior experience in oncology clinical development is preferred.

• Previous experience with global regulatory submissions is preferred.

• Willingness to travel around 10% of the time.

• Availability for evening and weekend work.

🏝️ Benefits

• Additional incentive cash and stock opportunities (based on eligibility).

• Medical, pharmacy, dental, and vision care.

• BMS Well-Being Account.

• BMS Living Life Better.

• Employee Assistance Programs (EAP).

• 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.

• Survivor support.

• Flexible time off (unlimited, with manager approval) for US Exempt Employees.

• 11 paid national holidays for US Exempt Employees.

• 160 hours of annual paid vacation for Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees.

• 11 national holidays and 3 optional holidays for Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees.

• Unlimited paid sick time, based on eligibility.

• Up to 2 paid volunteer days per year, based on eligibility.

• Summer hours flexibility, based on eligibility.

• Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.

• Annual Global Shutdown between Christmas and New Year's Day.

• Reasonable workplace accommodations/adjustments and ongoing support.