Principal Scientist, Bioinformatics

Job Summary

A company is looking for a Principal Scientist, Regulatory Bioinformatics.

Key Responsibilities

• Lead the design and execution of complex studies and analyses, including statistical modeling and genomic data interpretation
• Develop and validate algorithms and software solutions for medical device applications, ensuring compliance with regulatory standards
• Provide technical and strategic guidance to the bioinformatics team while overseeing regulatory submissions and documentation

Required Qualifications

• MS or PhD in Bioinformatics, Computational Biology, Computer Science, or a related field with at least 7 years of relevant experience
• Expertise in developing algorithms and software for medical devices, particularly in diagnostics
• Experience with statistical modeling and analytical validation for FDA regulated medical devices
• Proficiency in Python and bioinformatics tools used for genomic analysis
• Proven track record of working with regulatory bodies such as the FDA