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:
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Manage a team of biostatisticians, taking responsibility for their technical and professional development
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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
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Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation
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Effectively convey statistical concepts and results to cross-functional collaborators and stakeholders
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Directly influence and maintain departmental standards for the development and execution of analysis plans
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Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
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Perform other duties as assigned
QUALIFICATIONS:
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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
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Minimum of 2 years of diagnostic product or medical device development experience
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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:
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Expert working knowledge of statistical methodology in diagnostic medicine and assay/ device development, including CLSI guideline proficiency. Prior FDA/IVDR submission experience a plus.
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Prior experience with NGS and/or genetic testing a plus
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Aptitude for technical leadership. Proven record of leading a team a plus.
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Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
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Strong track record of producing high quality written documentation for multiple audiences
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Effective communication and interpersonal skills
