The individual will provide statistical expertise to shape and inform the overall development strategy for the company's growing oncology portfolio across phase 1-3 of clinical development.
Duties and Responsibilities
- Provide statistical expertise on study design, statistical analysis plans interpretation and communication of statistical results, project development plans, regulatory issues, and other product support projects.
- Develop collaborative relationships with stakeholders from research, CMC, clinical pharmacology, external development partners, and business development
- Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results in support of publication activities and product defense.
Qualifications
- Advanced degree in statistics, biostatistics, or related field.
- Minimum of 10 years clinical research experience in clinical development within a biotechnology and/or pharmaceutical company
- Ability to provide statistical leadership to cross-functional teams at both protocol and project levels.
- Strong statistical skills with application to clinical trials including survival analysis methodology.
- Expertise in the design, execution, and reporting of late stage clinical trials in oncology with small and/or large molecule drug candidates.