As a Senior Computational Biologist on the development team, you will play a key role in the development of noninvasive tests for early cancer detection. With a strong background in bioinformatics and data analysis, you will develop, execute, and produce analysis plans and reports for the development and characterization of our in vitro diagnostic devices and regulatory filings. You will work closely and cross-functionally with many teams, including Regulatory and Quality, Molecular Research and Development, Laboratory Operations, Computational Research, and Engineering to enable the successful development and launch of multiple molecular assays driving our cutting-edge diagnostic products.RESPONSIBILITIES
- Design and execute computational analysis plans and studies related to the performance of molecular features and assays, with a focus on plasma-based immunoassays.
- Develop Quality Control criteria based on experimental analysis and modeling
- Establish appropriate acceptance and analysis criteria for executed studies, closely partnering with Engineering and Laboratory Operations teams.
- Execute and author study reports under design control, working closely with Regulatory and Quality teams to design studies and requirements.
- Work closely with molecular and computational research teams developing our IVD products.
- Impact patient lives through the development and launch of high quality cancer screening technologies
- Advanced degree in statistics, bioinformatics, cancer biology, or related quantitative field.
- 2+ years industry experience
- Experience in experimental design and analysis of high-throughput, quantitative technologies in proteomics, genomics, epigenomics, or transcriptomics.
- Experience in the evaluation and application of appropriate statistical methods given a hypothesis and available data
Expertise in effective data analysis and visualization using Python, R, or equivalent, under version control.
Excellent oral and written communication skills to communicate to scientific and broader audiences, with keen attention to detail.
Ability to work on a cross-functional team in our highly collaborative environment,working with both computational and experimental scientists.Preferred
- Previous work in the development of diagnostic devices in a regulated environment (PMA, 510(k), CE-IVD)
- Experience in multiplexed immunoassays
- Expertise in building custom statistical models to quantify uncertainty and making appropriate conclusions
- Understanding of the generalized linear model framework including formulating model structure, model identifiability and model checking criterion