Senior Director, Biostatistics (Remote)

Why join Freenome?

Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease.

To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.

To fight the war on cancer, Freenome has raised more than $1.1B from leading investors including a16z, GV (formerly Google Ventures), T. Rowe Price, BainCapital, Perceptive Advisors, RA Capital Management, Roche, Kaiser Permanente Ventures, and the American Cancer Society’s BrightEdge Ventures.

Are you ready for the fight? A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrive in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. Freenomers are determined, patient-centric, and outcomes-driven. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. We are dedicated to advancing healthcare, one breakthrough at a time.

About this opportunity:

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.

What you’ll do:

• 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.

Must haves:

• 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.

Benefits and additional information:

The US target range of our base salary/hourly rate for new hires is $229,500 - $350,000. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits dependent on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ https://careers.freenome.com/ for additional company information.

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

#LI Biostatistics