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.