Senior Bioinformatics Scientist, Follow-On CDx

About the position 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. Requirements • PhD/Master level with 3+/5+ years related industry experience. • Experience with experimental design and associated statistical analysis (e.g., hypothesis testing, regression, hierarchical models, equivalence / non-inferiority). • Experience with interacting with medical diagnostic regulatory bodies (e.g. FDA, PMDA, EMA). • Experience with Python programming and Python data analysis libraries and tools (i.e. numpy, scipy, pandas, ipython notebooks, etc.). • Ability to develop analyses, models, reproducible code, and reports with Python. • Familiarity with data science software development practices. • Familiarity with genomic diagnostics. Nice-to-haves • Experience validating medical devices as companion diagnostics to competent authorities. • Experience with NGS technology and workflows. • Deep interest and active curiosity in improving medical technology and practice within a collaborative environment in cross-functional groups. Benefits • Hybrid work model with defined in-person and work-from-home days. • Competitive salary range with potential for bonuses and equity. Apply tot his job Apply tot his job