Biostatistician

Company Description
GeneGenieDx is a biotech company founded in 2020 in San Jose, California. Our current focus is on developing cutting-edge bioinformatics and machine learning algorithms to enable the discovery of novel biomarkers and translate them into clinical diagnostic applications.
You can learn more about us by visiting https://genegeniedx.com/
Job Description
We are looking for a highly motivated biostatistician(a consultant or contract role) with a strong background in molecular diagnostics development, and analytical, and clinical validation. He/she will lead the statistical design and development of our clinical diagnostic product.
Primary Responsibilities

• Lead the development of analytical frameworks and computational methods in IVD diagnostic clinical trials both clinical and analytical validation.
• Explore the usage of existing tools or pipelines and come up with novel algorithms when needed.
• Write production-level code and contribute to the codebase.
• Present findings and results to the team and collaborators.

Qualifications
Education Requirement

• A Master's or Ph.D. in statistics or biostatistics

Required Experience and Skills

• A minimum of 1-3 years of industry experience.
• Experienced in developing and validating laboratory diagnostic tests for qPCR or NGS, with expertise in Biomarker Discovery, Analytical Validation, Statistical Modeling, and Data Science, is essential.
• A proven track record in designing and successfully executing diagnostic clinical validation outcomes studies.
• Capable of establishing a biostatistics and data management quality system from the ground up.
• Effective communication and team engagement skills are a prerequisite.
• Programming proficiency with R, C, Visual Basic, UNIX, and SAS is required.

Preferred Experience and Skills

• Managerial experience
• Experience working with CROs is desirable.
• Knowledge of regulatory submission processes for early and late-phase oncology diagnostic development is highly advantageous.

Additional Information
This position is a consultant or contract role.