Bioinformatics Research Scientist
2 days ago
Overview: We are seeking a highly skilled Bioinformatics Scientist to join our follow-on CDx team. The successful candidate will work as part of a cross-functional team with Biostatistics, Regulatory, Technology Development, Medical Affairs, Business Development and Marketing teams. This role will provide bioinformatics support as a subject matter expert on next-sequencing (NGS) oncology diagnostic assays to help design and execute experiments in support of US and international regulatory submissions.
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.
Requirements:
- PhD/Master level with 0-2/4-6+ years related industry experience.
- Experience with experimental design and associated statistical analysis (e.g., hypothesis testing, regression, hierarchical models, equivalence / non-inferiority).
- 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.
- Experience with interacting with medical diagnostic regulatory bodies (e.g. FDA, PMDA, EMA).
- Experience validating medical devices as companion diagnostics to competent authorities.
- Experience with NGS technology and workflows.
Salary Range: $84,500 - $114,100 per year, depending on location and experience.
Location: Palo Alto, CA or Redwood City, CA.
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