POSITION SUMMARY:

This is an exciting opportunity to lead a Biostatistics team advancing Natera’s Women’s Health and Organ Health product portfolio of cutting-edge diagnostic assays. As a Manager, Biostatistics, you will leverage your medical device/assay development background along with your experience in applied statistics to oversee the design, analysis, and reporting of verification and validation experiments for multiple high-priority development projects. 

PRIMARY RESPONSIBILITIES: 

• Manage a team of biostatisticians, taking responsibility for their technical and professional development
• Oversee and provide technical guidance on the implementation and execution of relevant statistical analyses (e.g., sample size, power, accuracy, precision, LoD) for studies of varying complexity
• Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation
• Effectively convey statistical concepts and results to cross-functional collaborators and stakeholders
• Directly influence and maintain departmental standards for the development and execution of analysis plans
• Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
• Perform other duties as assigned

QUALIFICATIONS: 

• Master’s degree in Biostatistics, Statistics, Bioinformatics, Engineering, or equivalent with 4+ years of relevant experience, or PhD in Biostatistics, Statistics, or equivalent with 2+ years of relevant experience
• Minimum of 2 years of diagnostic product or medical device development experience
• Minimum of 3 years practical experience with statistical analysis software such as SAS, JMP, or R, or 4 years other relevant object-oriented programming experience

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert working knowledge of statistical methodology in diagnostic medicine and assay/ device development, including CLSI guideline proficiency. Prior FDA/IVDR submission experience a plus.
• Prior experience with NGS and/or genetic testing a plus
• Aptitude for technical leadership. Proven record of leading a team a plus.
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
• Strong track record of producing high quality written documentation for multiple audiences
• Effective communication and interpersonal skills