ABOUT GENALYTE

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego-based diagnostics company developing the Merlin platform, a novel photonic ring resonator-based system designed to deliver rapid, multiplexed diagnostic results. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

WHY WORK FOR US

Joining Genalyte at this pivotal pre-commercial stage means your work will have real, visible impact — on our technology, our culture, and ultimately on how diagnostic testing is delivered to patients. Regardless of your role, you'll be part of a collaborative team working closely with leadership to build something meaningful from the ground up. Genalyte offers competitive compensation including base salary, significant equity participation, and a comprehensive benefits package. This is a rare opportunity to grow alongside a high-impact company at a genuinely exciting moment in its journey.

POSITION SUMMARY

We are seeking a hands-on Scientific Data Scientist/Biostatistician to join our team to provide statistical analysis of complex data sets to support development of new assays and validation of clinical data. Proficiency in data analysis with a strong foundation in data validation, descriptive statistics, regression modeling and data visualization. Eager to collaborate with multidisciplinary research teams to clean datasets, generate accurate statistical outputs and support the development of new assays and validation of existing assays.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to: Data management: Design, build, and maintain robust data pipelines and automated workflows to ingest, clean, and process raw experimental data

Data Analysis and Modelling:

Analyzing large-scale diverse datasets using advanced statistical modeling to evaluate study results

Cross-Functional Collaboration:

Translate complex biological questions into quantitative hypotheses, working closely with wet-lab scientists and R D teams

Insight Communication:

Create clear data visualizations, dashboards, and technical reports to communicate findings to both technical and non-technical stakeholders

ADDITIONAL FUNCTIONS & RESPONSIBILITIES

Study Support:

Help design research experiments and validation protocols with appropriate sample sizes to meet acceptance criteria. Provide a statistical analysis plan and expected calculations to achieve the goals of the study

Regulatory Reporting:

Create data tables, figures and summary reports to share findings with the internal regulatory group and regulatory agencies in support of 510(k) submissions

Data Privacy:

Handle experimental, clinical, and patient-related data in compliance with HIPAA and applicable data privacy and security policies, maintaining strict confidentiality of sensitive research and regulatory information

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS & ABILITIES

Ph.D. or Master's degree in Data Science, Bioinformatics, Computer Science, Statistics, or a related STEM field + 2yrs experience

Programming:

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

Data Science:

Expertise in statistical analysis, experiment design, regression, clustering, and predictive modeling

Insight Communication:

Excellent verbal and written communication skills with the ability to explain complex quantitative results to scientists and executive leadership

Organization:

Strong project management skills and an ability to thrive in a fast-paced, matrixed biotech environment

Collaboration:

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

TRAVEL REQUIREMENTS

Minimal; occasional travel for industry conferences, partner meetings, or regulatory interactions (