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Salary: USD 105,000 - 120,000 / annual
Genalyte is a San Diego-based diagnostics company developing the Merlin platform, a novel photonic ring resonator-based system for rapid, multiplexed diagnostic testing. We are seeking a hands-on Scientific Data Scientist/Biostatistician to join our pre-commercial stage team and provide statistical analysis of complex datasets to support assay development and clinical data validation.
You will be responsible for designing and maintaining robust data pipelines and automated workflows to ingest, clean, and process raw experimental data. You'll analyze large-scale diverse datasets using advanced statistical modeling to evaluate study results, and translate complex biological questions into quantitative hypotheses while working closely with wet-lab scientists and R&D teams. A key part of your role is creating clear data visualizations, dashboards, and technical reports to communicate findings to both technical and non-technical stakeholders.
Additional responsibilities include helping design research experiments and validation protocols with appropriate sample sizes, providing statistical analysis plans and expected calculations to achieve study goals, and creating data tables, figures, and summary reports for regulatory submissions (510(k)). You will handle experimental, clinical, and patient-related data in compliance with HIPAA and applicable data privacy policies.
This is a primarily office-based role in San Diego with occasional visits to laboratory and engineering environments. Travel is minimal, with occasional trips for industry conferences, partner meetings, or regulatory interactions (<10%).
REQUIREMENTS:
- Ph.D. or Master's degree in Data Science, Bioinformatics, Computer Science, Statistics, or related STEM field
- 2+ years of experience
- Advanced proficiency in Python or JMP (and core scientific libraries like pandas, NumPy, SciPy)
- Data cleaning and validation, format conversion, merging and sorting of complex, multi-factor data
- Expertise in statistical analysis, experiment design, regression, clustering, and predictive modeling
- Excellent verbal and written communication skills with ability to explain complex quantitative results to scientists and executive leadership
- Strong project management skills and ability to thrive in a fast-paced, matrixed biotech environment
- Experience working with cross-functional teams (research, validation, clinical, regulatory) to interpret results
- Prior experience in medical devices, diagnostics (IVD), or healthcare technology in a regulated environment (CLSI, FDA guidance, 510(k), etc.) is highly preferred
