Guardant Healthis a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics.The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs.
In pursuit of our goal to manage cancer across all stages of the disease,Guardant Healthhas launched two liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
As a member of the Bioinformatics IVD development group, you will develop & execute bioinformatics analysis plans, author validation reports, & develop novel QC procedures for reagent manufacturing. You will work closely with multiple teams across Guardant Health, including Bioinformatics, Software, Technology Development, Regulatory, & Operations. Your work will be critical in the verification & validation of our in-vitro diagnostic & companion diagnostic products, resulting in more patients with access to precision treatment.
- Work closely with molecular biologists to troubleshoot & analyze verification & validation experiments as part of FDA PMA submission
- Develop & execute bioinformatics analysis plans with testable acceptance criteria
- Support reagent manufacturing through development of appropriately powered QC tests
- Conduct feasibility analyses & write development reports
- Identify & solve problems proactively as needed
- As a competitive candidate, you will have many of the following training, skills, & experience:
- Molecular diagnostics experience, with an emphasis on NGS approaches, desirable
- Experience designing, analyzing, troubleshooting, & 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 & 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, & bayesian models.
- Attention to detail, with ability to write clear & complete validation reports
- Commitment to reproducible research
- Desire to contribute to personalized medicine & innovative cancer care
- Ability to work under fast-paced startup environment
MS or PhD in Bioinformatics, Statistics, Computational Biology, Cancer Genomics, or related quantitative field
PhD with 2+ related industry experience preferred
All your information will be kept confidential according to EEO guidelines.