Senior Director, Epidemiology and Biostatistics

About 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.

About the Role

The Senior Director, Epidemiology and 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.  

Your contribution:

• 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.

Your background, perspective and experience: 

• 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.

COVID safety:

As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy.  If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster.  If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.

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.

Funding

We have raised more than $1.1B from leading investors including Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures. 

Freenomers

A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. 

Freenomers are technical, creative, visionary, grounded, empathetic and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time. 

Benefits include but are not limited to:

• Competitive compensation 
• Pre-IPO equity
• Flexible PTO (exempt) and generous PTO (non-exempt) 
• Comprehensive health coverage, including medical, dental, and vision 
• Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
• 401(k) plan 
• $250.00 new hire stipend to enhance your home office experience
• Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts 

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Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)

• Equal Employment Opportunity (EEO)

• Employee Polygraph Protection Act (EPPA)

Notice to agencies:

Our in-house Talent Acquisition Team manages all employment opportunities at Freenome.  Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee. 

We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. 

Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you. 

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