Location: Remote
Job 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 and regulatory approval of innovative 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. As clinical programs mature, opportunities to establish and expand the biostatistics team will follow. Come join our team during this exciting time of growth and opportunities!
Job Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
- Serve as the lead biostatistician for clinical projects, developing and executing statistical strategies, study designs, and analyses.
- Collaborate closely with multidisciplinary project teams to ensure seamless timely communication and alignment of objectives.
- Identify and implement solutions to statistical and data analysis issues related to clinical trials & regulatory submissions.
- Review study-related documents, and review/validate deliverables from vendors, including CDISC data specifications and CSR outputs. Active participation in study related meetings.
- Provide expert statistical advice on study designs, leveraging advanced analytical capabilities for tasks such as simulations.
- Work with internal programmers to support regulatory requests, publications, DSUR/IB updates, and perform ad-hoc analyses as needed.
- Participate in the internal sponsor review of ongoing clinical data.
Education and Experience:
- An advanced degree in Statistics or Biostatistics (PhD or Master).
- At least 6 years of hands-on experience in the pharmaceutical industry for PhD, or 8 years of hands-on experience in the pharmaceutical industry for Master.
- Experience with innovative study designs.
- Prior experience in oncology is preferred.
- Excellent interpersonal and communication skills.
- Willing to travel approximately 10% of the time. Evening and weekend work will be involved.
- Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).
- Solid understanding of GCP and ICH guidelines.
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment:
The noise level in the work environment is usually moderate.
The starting compensation for this job is a range from $167,612-$226,769 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
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