Sr. Data Scientist, Assay Development

Location: Palo Alto, CA, United States; hybrid, with 1–2 designated in-office working days each week for employees living within 50 miles of Palo Alto

Salary: $130,000–$170,000 per year

Company

hirify.global develops blood-based cancer detection tests using machine learning, whole-genome sequencing data, and cell-free DNA fragmentomics. Its FirstLook Lung laboratory-developed test supports lung cancer screening and has not been cleared or approved by the FDA.

What you will do

• Design studies and analyze data to evaluate assay performance and inform product decisions.
• Develop statistical methods for production monitoring and qualification of reagents, controls, and instruments across LDT and IVD products.
• Assess reagent, instrument, software, and process changes and design and analyze bridging studies for LDT updates.
• Support verification, production transfer, and definition of acceptance criteria for LDT and IVD products.
• Support CLIA/CAP, NYS, and applicable FDA regulatory submissions with rigorous, documented analyses.
• Lead troubleshooting, investigations, root cause analysis, and evolving assay development while producing quality-system-compliant code.

Requirements

• Master’s degree in Statistics, Biostatistics, Applied Math, Bioinformatics, Engineering, or a related quantitative field; PhD preferred.
• At least five years of scientific data analysis experience, including at least three years using Python or R; Python is preferred.
• Strong foundations in probability and statistics, including hypothesis testing, confidence intervals, parameter estimation, equivalence testing, and variance components.
• Experience in a regulated diagnostics environment such as IVD or LDT, 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 when troubleshooting performance issues.
• Familiarity with Design of Experiments and quality methods including statistical process control, measurement systems analysis, and Six Sigma/DMAIC.

Nice to have

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

Culture & Benefits

• Work in a science-led, pragmatic environment focused on quality, transparency, rigor, and measurable impact.
• Collaborate across assay development, laboratory operations, quality, regulatory, and software teams.
• Contribute to products intended to improve cancer detection and health outcomes across diverse populations.
• Work in a hybrid arrangement with designated office days for employees living within 50 miles of Palo Alto.
• Equal opportunity employment with a stated commitment to diversity and non-discrimination.