Associate Director, Biostatistics
Bristol Myers Squibb
Summary
The Associate Director of Biostatistics at RayzeBio will play a crucial role in guiding the design, execution, and interpretation of statistical analyses for clinical trials, with the overarching goal of facilitating the successful development of innovative radiopharmaceutical therapies. This position requires not only a deep understanding of biostatistical methodologies but also the ability to provide strategic guidance and expert insights throughout the drug development process.
Job description
Job 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 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.
Skills and Knowledge
- 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.
- Familiarity with statistical programming tools (e.g., SAS and/or R) and working knowledge of CDISC standards (SDTM/ADaM), with the ability to review and interpret key statistical outputs.
- Demonstrated ability to oversee vendors and ensure the quality, timeliness, and compliance of biometrics deliverables.
- Solid understanding of GCP, ICH guidelines, and regulatory requirements.
- Applies AI to improve team execution and decision-making.
Basic 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.
Preferred Requirements
- Prior experience in oncology clinical development.
- Prior experience with global regulatory submissions.
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)
- Working knowledge of CDISC standards (SDTM/ADaM)
- Solid understanding of GCP, ICH guidelines, and regulatory requirements
- Excellent interpersonal and communication skills
- Ability to influence cross-functional stakeholders
- Demonstrated ability to oversee vendors and ensure quality, timeliness, and compliance of biometrics deliverables
- Prior experience in oncology clinical development (preferred)
- Prior experience with global regulatory submissions (preferred)
Benefits
- Wellbeing support
- Retirement benefits
- Financial protection benefits
- Medical, Dental & Vision
- Life insurance
- Disability insurance
- Flexible Time Off
- Paid company holidays
- Paid sick leave
- Paid volunteer days
- Summer hours flexibility
- Leaves of absence
- Annual global shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.