Director Biostatistician
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-08-05
Listing for:
Greenkey Resources LLC
Full Time
position Listed on 2026-08-05
Job specializations:
-
Research/Development
Regulatory Compliance Specialist, Research Scientist, Clinical Research
Job Description & How to Apply Below
Overview
- Lead statistical methodologies for oncology clinical trials, ensuring innovative designs and regulatory compliance.
- Collaborate with cross‑functional teams to optimize study designs and data analysis.
- Provide expert guidance to enhance trial outcomes and mitigate risks effectively.
- Represent biostatistics in regulatory interactions, aligning with industry standards.
- Develop and refine departmental policies to improve operational efficiency and compliance.
- Manage vendor relationships to ensure quality deliverables and adherence to timelines.
- Contribute to strategic planning for oncology research initiatives and study designs.
- Drive innovation in statistical approaches to advance therapeutic development.
- Design and implement statistical analyses for oncology trials, ensuring methodological rigor and accuracy.
- Review and approve study protocols, case report forms, and statistical analysis plans.
- Perform advanced statistical analyses and interpret findings for clinical applications.
- Develop integrated safety and efficacy summaries for regulatory submissions.
- Engage with regulatory agencies to align on project development strategies.
- Evaluate vendor performance and manage contracts to ensure project success.
- Lead statistical contributions to major clinical programs and therapeutic areas.
- Collaborate with cross‑functional teams to ensure seamless execution of trials.
- PhD in Statistics, Biostatistics, or related field with 10+ years of experience.
- Extensive expertise in statistical design and analysis for oncology trials.
- Proficiency in statistical software such as SAS, R, and nQuery.
- Strong knowledge of CDISC standards and global regulatory guidelines.
- Experience managing external vendors and leading multidisciplinary teams.
- Proven track record in Phase III trials and regulatory submissions.
- Exceptional communication and leadership skills to drive project success.
- Ability to work onsite full‑time, with relocation assistance available.
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