Scientist I/II, Biostatistics

Job Description

Job Description

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. At this time, we will not be offering relocation assistance for this position. 

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 (<10%).

PHYSICAL REQUIREMENTS & WORK ENVIRONMENT

This is a primarily office-based role in San Diego, CA. Occasional visits to laboratory and engineering environments may be required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

COMPENSATION

The base salary range for this role is $105,000 - $120,000 per year. Individual pay may vary based on job-related skills, experience, and relevant education or training. In addition to base salary, this role includes meaningful equity participation, eligibility for the annual target bonus plan, and a comprehensive benefits package (health, dental, vision, and flexible time off policy).

EQUAL EMPLOYMENT OPPORTUNITY

Genalyte, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.