Staff Bioinformatics Scientist, IVD Development

Staff Bioinformatics Scientist, IVD Development

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Job Description

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 member of the Bioinformatics IVD Development group, you will develop and execute bioinformatics analysis plans, design pilot and formal studies, and author study reports. You will support the development and validation of our liquid biopsy technologies by leading the design and analysis of experiments to validate and characterize medical diagnostics. You will apply and develop new analytical and statistical methods to describe results internally and externally to partners or regulatory agencies. Expertise in bioinformatics, data analysis, and experimental design will be integral to the strategy for the full team including Operations, Regulatory Affairs, QA, Software Engineering, and 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.

• Work with molecular biologists to troubleshoot and analyze verification and validation experiments as part of FDA PMA submissions

• Develop statistical methods and procedures to describe and validate Guardant’s technologies

• Develop and execute bioinformatics analysis plans with testable acceptance criteria

• Write experimental protocols and reports in collaboration with assay development scientists

• Propose and present detailed designs and concise, well-written reports to a cross-functional teams

• Conduct feasibility analyses, including simulations drawing from a rich database of historical test results

• Mentor junior bioinformatics staff on the team

• Identify and solve problems proactively as needed

As a competitive candidate, you will have many of the following training, skills, and experience:

• Experience designing, analyzing, troubleshooting, and visualizing experiments
• Bioinformatics skills in genomics, sequence analysis, python or R under version control
• 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 the ability to write clear, concise, complete reports you should be bothered by outliers, edge cases, and unexpected results and be able to make a plan to resolve them
• Preferred experience developing or validating tests or devices in a regulated environment; IVD and/or Companion Diagnostic (CDx) development experience a plus
• Desire to contribute to personalized medicine and innovative cancer care

• Ph.D.in Bioinformatics, Statistics, Computational Biology, Cancer Genomics, or related quantitative field

• 4+ years of industry experience (MS & 6+ years industry experience)

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Additional Information

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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