The Senior Data Scientist will collaborate with a cross-functional team of laboratory scientists, clinicians, engineers, and other data scientists to develop statistical analysis methods supporting early cancer detection assays. This role spans assay development, analytical validation, and QC and control strategy, contributing to products advancing through verification, validation, and regulatory submission toward clinical use. The ideal candidate brings strong foundations in probability theory and statistics, applied experience in a regulated diagnostics or similarly rigorous data environment, and the ability to translate complex analyses into clear documentation for cross-functional and regulatory audiences.
What You'll DoDesign and execute analyses supporting assay development, analytical validation, and QC and control strategy, applying statistical methods appropriate to regulated diagnostic development
Collaborate cross-functionally with assay development, lab operations, and software teams to design experiments, interpret results, and produce documentation meeting quality system and regulatory standards.
Contribute statistical and data science expertise to control strategy development, including qualification and monitoring frameworks for reagents, instruments, and sample level QC.
Provide operational data science support for production and LDT/IVD run monitoring, including troubleshooting assay performance issues, trending QC metrics, and supporting root cause investigations.
Produce high quality Python code following best practices established by the software development team.
Support regulatory submissions (CLIA/CAP, NYS, FDA as applicable) with rigorous, well documented analysis.
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Salary: $160000-220000
🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.
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