IVD Statistical Programmer
IVD Statistical Programmer
In this newly created role, reporting to the Director, IVD Biostatistics, the IVD Statistical Programmer at Freenome will be responsible for authoring R or Python code to develop content for Freenome’s analytical validation studies. Working closely with biostatisticians and computational biologists, you will contribute to planning and preparing analytical validation reports for Freenome’s in vitro diagnostic devices and regulatory filings.
- Partner cross-functionally with biostatisticians, computational biologists, and development scientists to produce content for analytical validation (AV) reports
- Generate statistical materials supporting communications with regulatory agencies as part of regulatory submissions
- Review and contribute statistical analysis plans (SAPs) and statistical analysis sections of verification and validation protocols and assist in analyzing data from development activities
- Author, verify and validate code and output of AV analysis conducted by other statisticians or computational biologists
- Generate statistical materials to aid communications with regulatory agencies as part of regulatory submissions and design history file documentation
- Work closely with other members of the biostatistics team to support consistent approaches to evidence generation for regulatory submissions and to uphold quality standards
- Work closely with other members of the biostatistics team to support consistent approaches to evidence generation for regulatory submissions and to uphold quality standards.
Your background, perspective and experience:
- Undergraduate or advanced degree in statistics, biostatistics or closely related field
- At least three years of professional experience in statistical programming in diagnostic device development
- Solid understanding of quality requirements for biostatistics, programming, and data management
- Strong programming skills in R and Python and familiarity with SQL
- Proficiency with MS Office, Google Suite, Google Cloud Platform
- Excellent written, verbal, and data visualization skills
- Ability to manage multiple projects and priorities simultaneously.in a dynamic team environment.
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.
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.
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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