Sr. Data Scientist, Assay Development
Core
Develop statistical analysis methods for early cancer detection assays, supporting analytical validation, QC strategy, and regulatory submissions for blood-based diagnostic tests.
Role type
Senior IC data scientist (assay development & validation)
Builds
Laboratory-developed tests (LDT) for cancer screening
Domain
Diagnostics / Genomics / Oncology
Deliverable
production ML models | product features | dashboards & analysis
Required skills
probability theory, statistics, hypothesis testing, confidence intervals, parameter estimation, variance components, Python (numpy, pandas), regulated diagnostics experience, assay chemistry understanding
Preferred skills
NGS assay development, high-dimensional genomic data analysis, machine learning implementation, Design of Experiments, Six Sigma/DMAIC
Technologies
Python, numpy, pandas
Responsibilities
Design and execute analyses for assay development and validation; Collaborate cross-functionally to design experiments and produce regulatory documentation; Contribute to control strategy development for reagents and instruments; Support production monitoring and root cause investigations; Produce high-quality Python code; Support regulatory submissions (CLIA/CAP, FDA)
Seniority
Senior, hands-on IC