POSITION SUMMARY:
This is an exciting opportunity to lead a team of biostatisticians and statistical programmers advancing Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As an Associate Director of Biostatistics, you will leverage your exceptional applied statistics and leadership background to oversee the design, analysis, and reporting of clinical trials for multiple high-priority oncology projects. You will develop and exemplify the strategic vision of the team and oversee the career development and productivity of multiple direct reports.
PRIMARY RESPONSIBILITIES:
- Direct a team of biostatisticians and statistical programmers, taking responsibility for their individual deliverables and growth (technical and professional)
- Oversee Biostatistics contributions to oncology product clinical validation projects
- Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity
- Produce and review high-quality documentation for cross-functional internal and external collaborators and stakeholders Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
- Continuously improve the efficiency and efficacy of team through innovative techniques and strategies
- Promote, refine, and develop departmental standards for the development and execution of statistical analysis plans.
- Manage contracts and deliverables provided by CROs as needed.
QUALIFICATIONS:
- Minimum of 6 years of clinical trial experience, including at least 2 years experience in a related industry such as diagnostics or oncology therapeutics.
- Masters in statistics, biostatistics, or equivalent; PhD preferred.
- At least 2 years of management experience.
- Previous regulatory submission experience.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Aptitude for technical leadership and strategic thinking
- Proven record of leading a successful team
- Expert working knowledge of statistical methodology in diagnostic medicine and clinical trial design, including FDA guidelines
- 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
- Prior experience with NGS, genetics, and/or oncology testing a plus
