Senior Director, Biostatistics (Remote)
Job Description
The Senior Director, Biostatistics role reports to the Chief Medical Officer and will lead biostatistical strategies, activities and teams related to Freenome’s clinical and analytical programs, which will support product development, regulatory submissions, payer coverage and reimbursement, and policy and advocacy initiatives.
These efforts will contribute to the development and commercialization of a portfolio of early cancer detection products based on both clinical and multiomic data that will enable payers, providers, and patients to catch cancers early, when curative intervention is most achievable. The candidate directly contributes to company success by increasing the strength of study designs, interpretability of results, regulatory strategy & interactions, biomarker strategies and by implementing appropriate statistical methods of enhanced quantitative IVD development.
Responsibilities
- Define strategic vision for the clinical and analytical biometrics group, including the hiring, mentoring and retention of a world class team.
- Provide leadership to the biometrics team, including support for study concept, design and analysis.
- Actively interact with research, development, and clinical data management functions.
- Represent biostatistics in interactions with regulatory agencies.
- Oversee the design and analysis for Freenome’s clinical and analytical studies, including drafting or reviewing of study protocols and statistical analysis plans.
- In collaboration with cross-functional teams, oversee reporting of clinical and analytical studies for regulatory submissions, health technology assessments (HTAs), and publications.
- Collaborate with external thought leaders, academic entities, and vendors in the conduct of studies.
- Serve as an internal subject matter expert on biostatistical approaches for analytical and clinical research.
- Be accountable for study level and statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans.
- Identify opportunities to utilize innovative statistical methodology to facilitate optimal decision-making.
- Comply with all statistics and quality processes and Freenome data standards that are applicable to statistical outputs, and support processes that require statistical input.
Job Requirements
- Ph.D. in statistics, biostatistics, cancer epidemiology, or related scientific field with a minimum of ten years of directly relevant experience.
- Demonstrated experience with successful FDA interactions/submissions in support of both analytical and clinical validation studies.
- Demonstrated ability to work cross-functionally with research & development, regulatory, data management and quality teams.
- A strong track-record of leadership, mentoring and developing teams.
- Experience designing and conducting traditional clinical studies for diagnostic, medical device, or therapeutic product development.
- IVD/FDA submission experience strongly preferred.
