Sr. Data Scientist, Assay Development
About The Position
The Senior Data Scientist partners 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 help products perform reliably, including performance monitoring frameworks, change impact assessments, bridging studies for LDT updates, and support for verification and transfer to production. As products evolve, the role also contributes to assay development. The position calls for strong statistical foundations, regulated diagnostics experience, and the ability to work independently across later stages of the product lifecycle. DELFI Diagnostics develops blood-based tests that use machine-learning methods applied to whole-genome sequencing data. Its fragmentomics platform analyzes patterns and characteristics of cell-free DNA fragments. FirstLook Lung is the company’s first laboratory-developed screening test and is intended for individuals eligible for lung cancer screening. The test has not been cleared or approved by the FDA. DELFI has one to two designated in-office working days each week for employees who live within 50 miles of Palo Alto, California.
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 using Python or R; Python is 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, such as IVD, LDT, or similar, including designing, analyzing, and documenting verification, validation, or change assessment studies.
- 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, including statistical process control, measurement systems analysis, and Six Sigma/DMAIC.
Nice To Haves
- PhD in a relevant quantitative field.
- 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, including CLIA/CAP, New York State, and FDA submissions 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, preferably in Python or alternatively in R, that meets quality system and software team standards.
Benefits
- Flexible time-off policy.
- 401(k) retirement plan.
- Medical, dental, and vision coverage.
- Onsite lunch three days a week.
- Wellness-related offerings.
- The role may be eligible for an annual bonus and a new-hire equity grant, subject to applicable plan terms and company discretion.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
