Director Biostatistician
Green Key Resources
Job DetailExperience Level DirectorDegree Type Doctor of Philosophy (PhD)Employment Full TimeWorking Type On SiteJob Reference 0000012355Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Shape statistical innovation in oncology trials, driving impactful research outcomes. Collaborate with experts in a dynamic environment to advance therapeutic development. Lead pivotal projects in a leadership role.Job DescriptionOverviewLead 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.Key Responsibilities & DutiesDesign 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.Job RequirementsPhD 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.
$153.3k - $284.7k
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University of California , San Francisco
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