Biostatistician, Liquid Biopsy Diagnostics

Biostatistician, Liquid Biopsy Diagnostics

Guardant Health, Inc. | San Diego, CA, 92140, US
Salary Range:$79,000 – $103,000 Salary range estimated by Zippia

Posted a month ago

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Guardant 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. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. These tests fuel development of its screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

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 provide patients with greater access to life-extending precision treatment. You will provide biostatistical insight and guidance to regulatory strategy and problem-solving. You will author materials for statistical analysis plans and study reports, design pilot and formal studies, and provide statistical support for regulatory and biopharmaceutical partner interactions. You will identify and develop appropriate statistical methods to meet real-world company needs, e.g., to characterize product performance, and communicate them clearly to internal and external stakeholders as well as regulatory agencies.

You will be a member of the highly collaborative Biostatistics Shared Service Core of the Corporate Core Bioinformatics team. You will strengthen product development and validation efforts by sharing your expertise in biostatistics, data analysis, analytical validation and experimental design in collaborative settings that include personnel from Bioinformatics, Operations, Regulatory Affairs, QA, Software Engineering, among others.

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.


* Identify appropriate statistical methods to describe and validate Guardant's technologies leading to regulatory approvals; develop novel statistical methods when necessary
* Contribute and guide statistical content for protocols and reports in collaboration with Bioinformaticists and assay development scientists; design and defend analytical experiments with clinical and contrived samples
* Guide and/or conduct feasibility analyses, including simulations drawing from a rich database of historical test results
* Identify and solve problems proactively as needed; work with bioinformaticists and molecular biologists to troubleshoot and analyze verification and validation experiments as part of FDA PMA and other regulatory submissions
* Clearly and succinctly communicate statistical solutions and rational to non-statistical internal and external stakeholders and regulatory authorities


* PhD or equivalent relevant experience in Pharmaceutical, Biotech or Diagnostic industry
* PhD-level experience with experimental design and associated statistical analysis (e.g., hypothesis testing, regression, hierarchical models) is required; ability to understand relationships between variables in complex assays and their effects on observed data is required; familiarity with NGS workflows and data analytic methods is strongly preferred
* Attention to detail, with the ability to develop and write clear, concise, complete statistical analysis plans and reports
* Deep interest and active curiosity in improving statistical methods and practices in support of biomedical technologies and NGS workflows
* Desire to contribute to personalized medicine and innovative cancer care
* Experience with either R or Python

Preferred Skills & Knowledge:

* Commitment to reproducible research is required; previous experience working in accordance to a quality system in a regulated environment
* Knowledge of CLSI and other guidelines for validation of diagnostic tests and experience developing or validating tests or devices in a regulated environment

Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant's COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

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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