Scientist I/II, Biostatistics

Genalyte•San Diego, CA

1d•$105,000 - $120,000•Onsite

About The Position

Genalyte is seeking a hands-on Scientific Data Scientist/Biostatistician to perform statistical analysis of complex datasets supporting the development of new assays and validation of existing assays and clinical data. The role requires strong capabilities in data validation, descriptive statistics, regression modeling, and data visualization, as well as collaboration with multidisciplinary research teams to clean datasets and generate accurate statistical outputs. The position is primarily office-based in San Diego, California, with occasional visits to laboratory and engineering environments. Occasional travel for industry conferences, partner meetings, or regulatory interactions is expected and will be less than 10%. Relocation assistance is not offered. The role includes a base salary range of $105,000–$120,000 per year, meaningful equity participation, eligibility for the annual target bonus plan, and a comprehensive benefits package. Individual pay may vary based on job-related skills, experience, and relevant education or training.

Requirements

Ph.D. or master’s degree in Data Science, Bioinformatics, Computer Science, Statistics, or a related STEM field.
At least 2 years of experience.
Advanced proficiency in Python or JMP, including core scientific libraries such as pandas, NumPy, and SciPy.
Experience with data cleaning and validation, format conversion, and merging and sorting complex, multi-factor data.
Expertise in statistical analysis, experiment design, regression, clustering, and predictive modeling.
Excellent verbal and written communication skills, including the ability to explain quantitative results to scientists and executive leadership.
Strong project management skills and ability to thrive in a fast-paced, matrixed biotech environment.
Ability to collaborate with cross-functional research, validation, clinical, and regulatory teams to interpret results.
Ability to handle sensitive research and regulatory information confidentially and in compliance with HIPAA and applicable data privacy and security policies.

Nice To Haves

Prior experience in medical devices, diagnostics (IVD), or healthcare technology in a regulated environment, including familiarity with CLSI, FDA guidance, or 510(k) submissions.

Responsibilities

Design, build, and maintain data pipelines and automated workflows to ingest, clean, and process raw experimental data.
Analyze large and diverse datasets using statistical modeling to evaluate study results.
Translate biological questions into quantitative hypotheses in collaboration with wet-lab scientists and R&D teams.
Create data visualizations, dashboards, and technical reports for technical and non-technical stakeholders.
Help design research experiments and validation protocols, including appropriate sample sizes to meet acceptance criteria.
Provide statistical analysis plans and expected calculations to achieve study goals.
Create data tables, figures, and summary reports for internal regulatory groups and regulatory agencies in support of 510(k) submissions.
Handle experimental, clinical, and patient-related data in compliance with HIPAA and applicable data privacy and security policies, maintaining confidentiality of sensitive research and regulatory information.