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D

Senior Data Scientist, Assay Development

Delfi Diagnostics

. Partner with assay development, lab operations, quality, regulatory, and software teams to support LDT and IVD early cancer detection assays moving from late development into commercial use .

Posted 11/6/2026full-timePalo Alto • California • United StatesSenior💰 $130,000 - $170,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in statistical analysis and study design for LDT and IVD products, with a strong foundation in probability theory and experience in regulated diagnostics environments. Proficient in Python or R for data analysis and capable of leading cross-functional teams in troubleshooting and performance evaluation.

Highest-signal resume keywords
Statistical AnalysisPython ProgrammingRegulated Diagnostics ExperienceStudy Design LeadershipDesign Of Experiments

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Statistical MethodsData AnalysisHypothesis TestingConfidence IntervalsParameter EstimationVariance ComponentsVerification StudiesValidation StudiesChange Assessment StudiesAssay Development
Soft Skills
Cross-Functional CollaborationTroubleshootingIndependent Leadership
Tools & Technologies
PythonRStatistical Process ControlMeasurement Systems AnalysisSix SigmaNGS-Based Assays
Certifications & Qualifications
Master’s DegreePhD Preferred
Industry Keywords
LDTIVDFDA Design ControlsCLIACAPAssay TransferProduction MonitoringLot QualificationSequencing QCBatch Variability

Tech Stack

Tools & technologies
Python

About the role

Key responsibilities & impact
  • Partner with assay development, lab operations, quality, regulatory, and software teams to support LDT and IVD early cancer detection assays moving from late development into commercial use
  • 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
  • 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 for CLIA/CAP, NYS, and FDA as applicable with rigorous, well-documented analyses
  • Lead data analysis for troubleshooting, investigations, and root cause analysis
  • Contribute to assay development as products evolve
  • Produce well-documented code meeting quality system and software team standards

Requirements

What you’ll need
  • 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
  • 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)
  • PhD preferred
  • 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

Benefits

Comp & perks
  • Annual bonus eligibility
  • New hire equity grant eligibility
  • Flexible time-off policy
  • 401(k) retirement plan
  • Medical coverage
  • Dental coverage
  • Vision coverage
  • Onsite lunch 3 days a week
  • Wellness-related offerings
  • 1–2 designated in-office working days each week for employees living within 50 miles of Palo Alto, CA