Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. 

In pursuit of our goal to manage cancer across all stages of the disease, Guardant Health has launched two liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, and is developing programs for recurrence and early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

As a member of the Bioinformatics IVD development group, you will develop and execute bioinformatics analysis plans, author validation reports, and develop novel QC procedures for reagent manufacturing.  You will work closely with multiple teams across Guardant Health, including Bioinformatics, Software, Technology Development, Regulatory, and Operations. Your work will be critical in the verification and validation of our in-vitro diagnostic and companion diagnostic products, resulting in more patients with access to precision treatment.

Responsibilities 

• Work closely with molecular biologists to troubleshoot and analyze verification and validation experiments as part of FDA PMA submission
• Develop and execute bioinformatics analysis plans with testable acceptance criteria
• Support reagent manufacturing through development of appropriately powered QC tests
• Conduct feasibility analyses and write development reports
• Identify and solve problems proactively as needed

Qualifications

• As a competitive candidate, you will have many of the following training, skills, and experience:
• Molecular diagnostics experience, with an emphasis on NGS approaches, desirable
• Experience designing, analyzing, troubleshooting, and visualizing wet lab experiments
• Demonstrable expertise in genome scale data analysis
• Bioinformatics skills in genomics, sequence analysis, python or R scripting under version control
• Awareness and experience with current landscape of bioinformatics tools
• IVD and/or Companion Diagnostic (CDx) development experience a plus
• Working knowledge of statistical methods, including: hypothesis testing, conditional probability, regression modeling, goodness-of-fit tests, maximum likelihood, and bayesian models.
• Attention to detail, with ability to write clear and complete validation reports
• Commitment to reproducible research
• Desire to contribute to personalized medicine and innovative cancer care
• Ability to work under fast-paced startup environment

Education:

MS or PhD in Bioinformatics, Statistics, Computational Biology, Cancer Genomics, or related quantitative field

PhD with 2+ related industry experience preferred

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