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.

Essential Duties and Responsibilities:

This position will require working hours that cross between US and Japan business hours, such as 1pm – 9pm PST or similar times.

 As a bioinformatics scientist in the IVD Development team you will work as part of a cross-functional team with Regulatory, Laboratory Operations, 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 and help design and analytically execute experiments to support regulatory submission that will get more and better testing to patients. This position is responsible for bioinformatics data analysis and documentation for international regulatory submission, including authoring development and laboratory validation reports. You will also sustain and support efforts for laboratory testing in labs outside of the US. A key component of the position is to help maintain alignment and knowledge transfer between Guardant operations in Japan with US regulatory and diagnostic development efforts.

• Understand regulatory submission documentation and relay relevant information to the Regulatory team.
• Understand and defend analytical experiments.
• Understand statistical methods and procedures used in clinical assay validations.
• Interface with the US bioinformatics team to support the Regulatory team and regulatory agency inquiries.
• Author required development reports using existing data set.
• Analyze and author laboratory NGS assay validation results.
• Sustain and Support production laboratory testing, including Quality Control results, patient results and reports.

Qualifications:

• Ph.D. in computational biology/bioinformatics, genomics, machine learning, or related fields and 2+ years industry/academia experience, OR MS and 5+ years industry/academia experience.

• Familiar with NGS data formats and tools

• Ability to develop analyses, models, and reproducible reports with Python or R
• Experience developing or validating tests or devices in a collaborative or regulated environment
• Experience troubleshooting, maintaining, or launching of a medical product is preferred
• Experience analyzing, troubleshooting, and visualizing wet lab experiments

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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.