Bioinformatics Research Scientist

2 days ago


Palo Alto, California, United States ZipRecruiter Full time

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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