- Palo Alto, California, United States
- Full-time · Senior
- 5+ years
Senior Data Scientist partnering with assay development, lab operations, quality, regulatory, and software teams to support early cancer detection assays.
Responsibilities
- Design studies and analyze data to evaluate assay performance
- Develop statistical methods for production monitoring and qualifying reagents, controls, and instruments
- Assess impact of reagent, instrument, software, and process changes and design bridging studies
- Support verification and transfer to production for LDT and IVD products
- Support regulatory submissions with rigorous analyses
Requirements
- Master’s degree in Statistics, Biostatistics, Applied Math, Bioinformatics, Engineering, or related quantitative field; PhD preferred
- Nice to have: production monitoring
- Nice to have: lot qualification
- Nice to have: post‑market changes
- Nice to have: assay transfer