Associate Director, Biostatistics

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

📋 Description

• Act as the primary biostatistician for clinical oncology initiatives.

• Design and implement statistical strategies, study frameworks, and analyses.

• Offer biostatistical expertise during interactions with international health authorities, including the FDA and EMA.

• Assist in the preparation of briefing documents, responses to agency questions, and submission dossiers.

• Collaborate with interdisciplinary project teams to synchronize objectives and ensure effective communication.

• Recognize and address statistical and data-analysis challenges for clinical trials and regulatory submissions.

• Author and manage the statistical sections of protocols, statistical analysis plans, and TLF shells.

• Evaluate study-related documents and verify vendor outputs, including CDISC data specifications and TLF/analysis results.

• Work alongside statistical programmers on regulatory inquiries, DSUR/IB updates, publications, and special analyses.

• Engage in sponsor reviews of ongoing clinical data to maintain integrity and identify efficacy and safety patterns.

• Investigate, trial, and assist in the implementation of AI-driven tools and processes to enhance quality control and operational efficiency.

• Contribute to the advancement of radiopharmaceutical therapies through early-phase dose optimization, registrational trials, and regulatory submissions.

⛳️ Requirements

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

• Minimum of 6 years of biostatistics experience in the pharmaceutical/biotech sector for PhD graduates, or 8 years for MS graduates.

• Experience in clinical development within oncology.

• Familiarity with Bayesian methods in a clinical development context.

• Proficient in statistical software such as SAS, R, and EAST, including trial design simulations.

• Working knowledge of CDISC standards, including SDTM and ADaM.

• Ability to assess and interpret critical statistical outputs.

• Capability to supervise vendors and ensure the quality, timeliness, and compliance of biometrics deliverables.

• Strong understanding of GCP, ICH guidelines, and global regulatory standards.

• Extensive knowledge of statistical methodologies for oncology trials.

• Exceptional interpersonal and communication abilities.

• Competence to operate in a highly regulated environment while adhering to RayzeBio protocols and SOPs.

• Willing to travel about 10% of the time.

• Occasional evening and weekend work may be necessary.

🏝️ Benefits

• Wellbeing support.

• Retirement and financial protection benefits.

• Offerings for medical, dental, vision, life, and disability insurance.

• Flexible Time Off (FTO) for exempt employees based in the U.S.

• 11 paid company holidays each year.

• 160 hours of paid vacation annually for new hires who are non-exempt employees, RayzeBio employees, and employees in Puerto Rico.

• 3 optional holidays for non-exempt employees, RayzeBio employees, and employees in Puerto Rico.

• Paid sick leave, subject to eligibility.

• Up to two paid volunteer days each year.

• Flexible summer hours.

• Medical, personal, parental, caregiver, bereavement, or military leaves of absence.

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

• Reasonable workplace adjustments and ongoing support for individuals with disabilities.

• Additional discretionary cash and stock incentive opportunities may be available.