Senior Bioinformatics Scientist, Follow-On CDx

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield test, aims to address the needs of individuals eligible for cancer screening.

About the Role:

Your work will be critical in the analytical and clinical validation of in-vitro diagnostic products and subsequent regulatory approval as companion diagnostics (CDx) for new therapeutics in the US and internationally. This work allows Guardant Health and its partner pharmaceutical companies to ensure that patients can find a life extending therapy that best matches their cancer.

As a Senior Bioinformatics Scientist in the follow-on CDx team, you will work as part of a cross-functional team with the Biostatistics, Regulatory, Technology Development, Medical Affairs, Business Development, and Marketing teams. A successful candidate in this position will be able to provide bioinformatics support as a subject matter expert on next-generation sequencing (NGS) oncology diagnostic assays to help design and execute experiments in support of US and international regulatory submissions. This will require individual contributions to experimental and protocol design, statistical analysis of genomic data, and development of novel methods for determining quality and accuracy of cutting-edge oncology tests.

Essential Duties and Responsibilities:

• Work with the Technology Development team to troubleshoot and analyze verification and validation experiments as part of FDA submissions (IDE, sPMA and PMA) and international submission.
• Design and develop software tools to automate analytical procedures.
• Develop or apply statistical methods and procedures to describe and validate Guardant Health technologies.
• Write and design experimental protocols and reports in collaboration with the technology development group.
• Propose and present detailed designs and concise, well-written reports to cross-functional teams.
• Conduct feasibility analyses, including simulations drawing from a rich database of historical test results and evaluation of external technologies.
• Leverage cutting edge AI methods to streamline analytical workflows and continuously improve submission efficiency and efficacy.
• Provide mentorship and technical guidance to less senior team members.

• PhD/Master level with 3+/5+ years related industry experience.
• Experience with experimental design and associated statistical analysis (e.g., hypothesis testing, regression, hierarchical models, equivalence / non-inferiority)
• Experience with interacting with medical diagnostic regulatory bodies (e.g. FDA, PMDA, EMA).
• Experience with Python programing and Python data analysis libraries and tools (i.e. numpy, scipy, pandas , ipython notebooks, etc.).
• Ability to develop analyses, models, reproducible code, and reports with Python
• Familiarity with data science software development practices
• Familiarity with genomic diagnostics

Preferred Qualifications

• Experience validating medical devices as companion diagnostics to competent authorities.
• Experience with NGS technology and workflows
• Deep interest and active curiosity in improving medical technology and practice within a collaborative environment in cross-functional groups.

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays.We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

The US base salary range for this full-time position is $102,000 to $163,200. The range does not include benefits, and if applicable, bonus, commission, or equity.The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $136,000 to $183,600. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment.Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment.Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out toPeopleteam@guardanthealth.com

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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Please visit our career page at:http://www.guardanthealth.com/jobs/

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