Staff IVD Biostatistician

Staff IVD Biostatistician 

About the role

Reporting to the Director, IVD Biostatistics, the newly created Staff IVD Biostatistician role will work closely and cross-functionally with Regulatory and Quality, Molecular Research and Development, Laboratory Operations, Computational Research, and Engineering to enable the successful development and launch of multiple molecular assays driving Freenome’s cutting-edge diagnostic products. You will be responsible for statistical activities supporting Freenome’s analytical validation studies and will contribute to our analytical protocols and reports and engage in responses to regulatory bodies. 

How you’ll contribute

• Partner cross-functionally with Research and Development, Clinical Laboratory, Regulatory and Quality Affairs, Scientific and Medical Affairs, and Clinical Development to develop validation study designs
• Generate statistical materials supporting communications with regulatory agencies as part of regulatory submissions
• Author statistical analysis plans (SAPs) and statistical analysis sections of verification and validation protocols and
•  Support data interpretation and assist in interpreting data from development activities
• Generate statistical materials to aid communications with regulatory agencies as part of regulatory submissions and design history file documentation 
• Provide statistics guidance and contributions to cross-functional R&D teams and clinical development teams
• Assist with the design of experiment activities, protocol development, and statistical analysis of analytical validation studies
• Contribute to the computation of power calculations and statistical modeling, including code generation, audit, and validation
• Work closely with other members of the biostatistics team to support consistent approaches to evidence generation for regulatory submissions and to uphold quality standards.
• May support clinical trial design, execution, analysis, and quality control method development and validation
• Represent Biostatistics on Core Teams and support clinical trial design, execution, analysis, and quality control method development and validation, as needed.

Your background, perspective, and experience

• Ph.D. or Master’s in statistics, biostatistics, epidemiology, or related scientific field 
• At least ten  years of closely related professional experience in a diagnostic device development setting
• Proficient understanding of quality requirements for biostatistics, programming, data management, and strategies supporting product development and regulatory submissions
• Excellent written, verbal, and  data visualization skills
• Advanced programming skills in R and/or Python
• Proficiency in experimental study design, MS Office, Google Suite, and cloud computing environments (Google Cloud Platform)
• The ability to multitask, prioritize, and work with a sense of urgency and purpose.

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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