Senior Data Scientist, Diagnostics & Assay Performance

Delfi Diagnostics, Inc.; Palo Alto (CA); On-site; USD 150,000 - 230,000; Full time

Job summary

Delfi Diagnostics, Inc. in Palo Alto, CA, seeks a Senior Data Scientist to partner with assay development, lab operations, quality, regulatory, and software teams to advance LDT/IVD diagnostic products.

You will design studies, analyze data, and build production monitoring frameworks ensuring robust performance as products move toward commercialization. The role requires strong statistical foundations, experience in regulated diagnostics, and ability to lead cross‑functional analyses.

Qualifications

• Master’s degree in Statistics, Biostatistics, Applied Math, Bioinformatics, Engineering, or a related quantitative field; PhD preferred.
• 5+ years of experience in scientific data analysis, with at least 3 years in Python or R.
• 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).

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.

Skills

Statistics

Study design

Python

R

Data analysis

Cross-functional collaboration

Education

Master’s degree in Statistics/Biostatistics/Applied Math/Bioinformatics/Engineering

PhD preferred

Tools

Python

R

Statistical software

Job description

Delfi Diagnostics, Inc. in Palo Alto, CA, seeks a Senior Data Scientist to partner with assay development, lab operations, quality, regulatory, and software teams to advance LDT/IVD diagnostic products.

You will design studies, analyze data, and build production monitoring frameworks ensuring robust performance as products move toward commercialization. The role requires strong statistical foundations, experience in regulated diagnostics, and ability to lead cross‑functional analyses.