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RayzeBio

Associate Director, Biostatistics

RemoteUnited States only
Published
Role
Data Science
Experience
Senior
Employment
Full-time
Company size
Mid-size
$189.7k–$229.8k/yr
Check eligibility

Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior biostatistician (Associate Director) for oncology clinical trials with 8+ years (PhD) or 10+ years (MS) industry experience. Must be US-eligible / work in the United States; strong experience with SAS and/or R, CDISC (SDTM/ADaM), GCP/ICH, vendor oversight, and statistical strategies for regulatory submissions. Experience applying AI tools to analytics/quality control is required.

Core skills

Biostatistics

Required skills

SASRCDISCSDTMADaMGCPICH

Optional skills

AI-enabled toolsexperience with global regulatory submissionsoncology clinical development

What you'll do

  • 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 review/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.
  • Willing to travel approximately 10% of the time.
  • Evening and weekend work will be involved.

What they require

  • Advanced degree in Statistics or Biostatistics (PhD or MS).
  • 8+ years (PhD) or 10+ years (MS) of biostatistics experience in the pharmaceutical/biotech industry.
  • Experience utilizing AI-enabled tools to improve productivity and work efficiency.
  • 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 SOPs.
  • Demonstrated ability to oversee vendors and ensure the quality, timeliness, and compliance of biometrics deliverables.
  • Solid understanding of GCP, ICH guidelines, and regulatory requirements.

Benefits

  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: BMS Well-Being Account, BMS Living Life Better, 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.
  • Paid Time Off: flexible time off (unlimited) for US Exempt Employees; 160 hours annual paid vacation for Phoenix, AZ / Puerto Rico and certain employees.
  • Additional time off options: unlimited paid sick time (based on eligibility), up to 2 paid volunteer days, summer hours flexibility, leaves of absence, annual Global Shutdown between Christmas and New Years Day.
  • Additional incentive cash and stock opportunities (based on eligibility).
  • Workplace accommodations and support for applicants with disabilities.

RayzeBio is a wholly-owned subsidiary of Bristol Myers Squibb developing transformative radiopharmaceutical therapies for patients living with cancer.

🇺🇸 United StatesBiotechStartup
$189.7k–$229.8k/yr