Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
The Principal Biostatistician will be an experienced leaderwho can bring their knowledge of biostatistics, data analysis, clinical & analytical validation study designs in support of in-vitro diagnostic development, & FDA interactions on complex technologies to individually contribute & technically mentor a team of talented data analysts, statisticians, & bioinformatics scientists. This unique position requires a combination of very high technical expertise with great management skills to provide guidance across the breadth of projects requiring biostatistics support for the technology team. The successful candidate will join cross-functional teams working across research & development projects, gaining expertise in understanding & interpretation of clinical genomics high throughput data. Enabling the culture of scientifically informed development of biostatistics in support of assay validation & successful submission & approval of validated assays is one of the keys to success. The company thrives by combining the best ideas & practices from molecular biology, bioinformatics, genomics, & clinical testing to improve healthcare for everyone.
The PrincipalBiostatistician will:
- Provide individual contribution & mentorship to the research & development team for the study design & analysis;
- Contribute to strategic vision for the biostatistics group at Guardant Health;
- Actively interact with research & development scientists on understanding genomic technologies at the core of Guardant's products & collaborate in establishing appropriate validation study designs;
- Represent biostatistics in interactions with regulatory agencies;
- Represent Guardant in collaborations with pharmaceutical companies & in support of clinical data management for their trials;
- Work across Guardant Health to provide biometrics / biostatistics support for clinical trials & new assay validation;
- PhD in biostatistics or related field;
- 7-10+ years of experience with a minimum of 5 years' experience managing people & projects in biostatistics for IVD development, biometrics, statistical inference;
- Demonstrated experience with successful FDA interactions in support of both analytical & clinical validation studies for emerging & complex technologies;
- Demonstrated ability to work cross-functionally with research & development, regulatory, & quality teams in developing study protocols;
- A strong track-record of leadership, mentoring, & developing teams that realize a potential greater than the sum of the parts.
Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & biohazard material in the laboratory environment. Ability to sit for extended periods of time.
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status & will not be discriminated against on the basis of disability.
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Please visit our career page at:http://www.guardanthealth.com/jobs