Sr. Data Scientist, Assay Development

DELFI Diagnostics • Palo Alto, CA

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About The Position

The Senior Data Scientist will partner with assay development, lab operations, quality, regulatory, and software teams to support DELFI’s LDT and IVD early cancer detection assays as they move from late development into commercial use. The role focuses on study design and data analysis that keep products performing reliably, including performance monitoring frameworks, change impact assessments, and bridging studies for LDT updates, as well as supporting verification and transfer to production. As products evolve, this person will also contribute to assay development. The ideal candidate brings strong statistical foundations, experience in regulated diagnostics, and the ability to work independently across the later stages of the product lifecycle.

Requirements

• Master’s degree in Statistics, Biostatistics, Applied Math, Bioinformatics, Engineering, or a related quantitative field.
• Five or more years of experience in scientific data analysis, including at least three years in Python or R (Python preferred).
• Strong foundations in probability theory and statistics, including hypothesis testing, confidence intervals, parameter estimation, equivalence testing, and variance components.
• Experience in a regulated diagnostics environment (IVD, LDT, or similar), including designing, analyzing, and documenting verification, validation, or change assessment studies.
• Demonstrated ability to independently lead study design and analysis with cross-functional teams.
• Ability to connect assay chemistry to data behavior to troubleshoot performance issues.
• Familiarity with Design of Experiments and related quality methods (statistical process control, measurement systems analysis, Six Sigma/DMAIC).

Nice To Haves

• PhD.
• Experience supporting launched assays, including production monitoring, lot qualification, or post-market changes.
• Experience supporting assay transfer from development into production or a clinical laboratory.
• Exposure to NGS-based assays, including sequencing QC and batch variability.
• Familiarity with FDA design controls and IVD submissions.

Responsibilities

• Design studies and analyze data to evaluate assay performance and inform product decisions.
• Develop statistical methods for production monitoring and for qualifying reagents, controls, and instruments across LDT and IVD products.
• Assess the impact of reagent, instrument, software, and process changes, and design and analyze bridging studies for LDT updates.
• Support verification and transfer to production for LDT and IVD products, including defining acceptance criteria.
• Support regulatory submissions (CLIA/CAP, NYS, FDA as applicable) with rigorous, well-documented analyses.
• Lead data analysis for troubleshooting, investigations, and root cause analysis, and contribute to assay development as products evolve.
• Produce well-documented code (Python preferred, R acceptable) that meets quality system and software team standards.

Benefits

• Flexible time-off policy.
• 401(k) retirement plan.
• Medical, dental, and vision coverage.
• Onsite lunch 3 days a week.
• Other wellness-related offerings.
• Potential eligibility for an annual bonus and new-hire equity grant, subject to applicable plans and Company discretion.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior