Full-Time Bioinformatics Scientist I, Follow-On CDx

About the Role: Your work is critical in the analytical and clinical validation of in-vitro diagnostic products and subsequent regulatory approval as companion diagnostics (CDx) for new therapeutics. This allows Guardant Health to ensure patients receive the best cancer therapy. You'll work with a cross-functional team.

Essential Duties and Responsibilities:

• Troubleshoot and analyze verification/validation experiments for FDA submissions (IDE, sPMA, PMA) and international submissions.
• Design and develop software tools to automate analytical procedures.
• Develop/apply statistical methods to describe/validate Guardant Health technologies.
• Write/design experimental protocols and reports.
• Propose/present detailed designs and reports.
• Conduct feasibility analyses (simulations, historical data, external technologies).
• Leverage AI methods to streamline workflows and improve submission efficiency.

Required Experience:

• PhD/Master's degree with 0-2/4-6+ years related industry experience
• Experience with experimental design and statistical analysis (hypothesis testing, regression, models)
• Experience with Python programming and data analysis libraries (NumPy, SciPy, Pandas, etc.)
• Ability to develop analyses, models, reproducible code, and reports
• Familiarity with data science software development practices

Preferred Experience:

• Interacting with medical diagnostic regulatory bodies (FDA, PMDA, EMA)
• Validating medical devices as companion diagnostics
• Experience with NGS technology and workflows

Work Model: Hybrid model, including in-person days.

Salary: $84,500 - $114,100 (Palo Alto/Redwood City: $105,600 - $142,600) - does not include benefits, bonus, commission, or equity.

Additional Details:

• Employee may lift office supplies, use equipment
• Majority of work is in a desk environment, potential exposure to noise, fumes, biohazard materials (labs).
• Ability to sit for extended periods.

Equal Opportunity Employer: Guardant Health is an equal opportunity employer.

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