Senior Biostatistician, IVD Development
- Home Or Remote Office, Virtual, All, United States
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and 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 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
About the role:
Be part of a team in the late scientific stages of making breakthrough medical diagnostics available for patients. You will support and drive the development and validation of new technologies by designing and analyzing experiments to validate and characterize their performance, develop analytical and other QC methods, and provide general statistical expertise in validation and use of complex diagnostics at scale. You will apply and develop new analytical and statistical methods to describe results internally and externally to partners or regulatory agencies. Expertise in biostatistics, data analysis, analytical validation and experimental design will be integral to the strategy for the full team including Operations, Regulatory Affairs, QA, Software Engineering, and others.
- Design and defend analytical experiments with clinical and contrived samples
- Develop statistical methods and procedures that describe and validate Guardant’s technologies leading to regulatory approvals
- Write experimental protocols and reports in collaboration with assay development scientists
- Support the increasing scale of running many thousands of samples per year by implementing appropriate QC and validation methods
- Propose and present detailed study designs and concise well-written reports to cross-functional teams
- PhD-level experience with experimental design and associated statistical analysis (e.g., hypothesis testing, regression, hierarchical models)
- Ability to develop, implement, and document statistical analysis plans
- Knowledge of CLSI and other guidelines for validation of diagnostic tests
- Ability to understand relationships between variables in complex assays and their effects in observed data; familiriaty with NGS workflows and data preferred
- Familiarity with random and fixed effect models, common model diagnostics, and other considerations pertaining to goodness of fit
- Experience with R and R libraries/tools including: glm, nlme, glmnet, tidyverse, Rmarkdown, parallel
- Experience with R Shiny and/or R plot_ly implementation preferred
- Experience with or capability to learn Python
- Experience working with high dimensioned data and familiarity with statistical challenges associated with such work (e.g., test multiplicity, dimension reduction, data normalization, outlier detection, etc.)
- Ability and motivation to build reproducible and well-written code or packages for data analysis
- Experience troubleshooting, maintaining, or launching of a medical product is preferred
- Deep interest and active curiosity in improving statistical methods and practices in support of biomedical technologies and NGS workflows
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and 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 and will not be discriminated against on the basis of disability.
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