This is an exciting opportunity to advance Natera's regulated product portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of clinical trials for regulatory submissions to support our oncology portfolio.
PRIMARY RESPONSIBILITIES:- Design and review statistical methodology in protocols and statistical analysis plans
- Lead execution of statistical analyses according to plans and protocols, as well as exploratory or ad-hoc analyses
- Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation
- Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders
- Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
- Mentor and provide technical supervision to junior team members
- Perform other duties as assigned
QUALIFICATIONS:- Master's degree in biostatistics, statistics, or equivalent with 5+ years of relevant experience, or PhD in biostatistics, statistics, or equivalent with 3+ years of relevant experience
- At least 3 years practical experience designing and executing statistical analyses in a regulated environment and clinical trials for regulatory submissions
- Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP
- Previous diagnostic experience preferred
KNOWLEDGE, SKILLS, AND ABILITIES:- Expert knowledge of probability theory and statistics including the ability to evaluate and produce novel methods and applications
- Familiarity with typical approaches, best practices, and regulatory standards in clinical trial design
- Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
- Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences
- Track record of producing high quality written documentation for multiple audiences
- Prior experience with next-generation sequencing (NGS), genetics, and/or oncology testing a plus
- Previous experience interacting with regulatory bodies such as the FDA preferred
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
Remote USA
$130,900-$163,600 USD
