Bioinformatics Scientist II, IVD Development

Company Description: 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 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 launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early-stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Your work will be critical in the verification and validation of our in-vitro diagnostic and companion diagnostic products, leading to regulatory approvals that will result in more patients with access to life-extending precision treatment. 

As a bioinformatics scientist in the IVD Development team you will work as part of a cross-functional team with Biostatistics, Regulatory, Technical Development, Medical Affairs, 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 analytically execute experiments in support of support 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. 

Guardant360 CDx was the first liquid biopsy approved by the FDA for treatment selection in non-small cell lung cancer and for pan-cancer tumor profiling. Our team is at the vanguard of liquid biopsy IVD development and needs you to extend our gains across our portfolio of tests. In this role, you will see the impact of your work quickly and at scale.

Responsibilities:

• Work with molecular biologists to troubleshoot and analyze verification and validation experiments as part of FDA PMA submissions
• Design and develop software tools to automate analytical procedures
• Develop and/or apply statistical methods and procedures to describe and validate Guardant’s technologies
• Write 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

Knowledge, Experience and Skills:

• PhD/Master level with 2+/4+ years related industry experience.
• Experience with experimental design and associated statistical analysis (e.g., hypothesis testing, regression, hierarchical models, equivalence / non-inferiority)
• Ability to develop analyses, models, and reproducible reports with Python or R
• Familiarity with data science software development practices

Preferred:

• Experience developing or validating tests, devices in a regulated environment, troubleshooting, maintaining, or launching of a medical product.  
• Familiarity with NGS technology and workflows
• Deep interest and active curiosity in improving medical technology and practice within a collaborative environment in cross-functional groups.

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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.