Senior Bioinformatics Scientist, Follow-On CDx - Palo Alto California

Company: Guardant Health
Location: Palo Alto, California
Posted On: 11/20/2024

Senior Bioinformatics Scientist, Follow-On CDx

• Full-timeGuardant 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.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.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 will provide bioinformatics support as a subject matter expert on next-generation sequencing (NGS) oncology diagnostic assays.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.Minimum Qualifications:
    • 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 programming 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.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.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.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.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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