About the Role:Your work will be critical in the analytical and clinical validation of in-vitro diagnostic products and subsequent regulatory approval as companion diagnostics (CDx) for new therapeutics in the US and internationally. This work allows Guardant Health and its partner pharmaceutical companies to ensure that patients can find a life extending therapy that best matches their cancer.As a Senior Bioinformatics Scientist in the follow-on CDx team, you will work as part of a cross-functional team with the Biostatistics, Regulatory, Technology Development, Medical Affairs, Business Development, 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 execute experiments in support of US and international 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. Essential Duties and Responsibilities:Work with the Technology Development team to troubleshoot and analyze verification and validation experiments as part of FDA submissions (IDE, sPMA and PMA) and international submission.Design and develop software tools to automate analytical procedures.Develop or apply statistical methods and procedures to describe and validate Guardant Health technologies.Write and design 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 and evaluation of external technologies.Leverage cutting edge AI methods to streamline analytical workflows and continuously improve submission efficiency and efficacy.Provide mentorship and technical guidance to less senior team members.
