Uses skills as a seasoned, experienced research professional with a full understanding of in-depth statistical analyses and/or research software programming techniques. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Involves technical expertise for planning and performing correlative analyses of biomarker and clinical data from the endocrine optimization pilot EOP I-SPY 2 sub-study trial, as well as the I-SPY suite of trials.
Specifically, the EOP I-SPY 2 sub-study trial evaluates the feasibility of neoadjuvant endocrine therapy +/- novel agents in molecularly low risk (but clinically high risk) HR+HER2- patients who screened out of the main I-SPY 2 trial. As a secondary aim, many biomarkers (expression-based, imaging, circulating, pathology-based, etc.) are collected, such that correlative studies can be performed. In addition, organoids are generated from tissue samples from selected patients in collaboration with Dr. Jennifer Rosenbluth for single cell sequencing and in vitro treatment sensitivity assays. The portfolio of biomarkers is expected to grow; dedicated bioinformatics support for performing correlative and integrative biomarker analyses to better understand the biology of endocrine responsiveness is needed.
The incumbent will provide bioinformatics and statistical support for EOP and other I-SPY studies, on a variety of projects assessing correlation between biomarkers evaluated at baseline and longitudinally to characterize patient endocrine therapy response. Work with trial investigators and the sponsor's biometrics team to support development and timely execution of bioinformatics and statistical analysis plans for collaborative studies that leverage biomarker and clinical data from the trial to address clinically and/or translationally relevant questions. Generate reports and presentations to communicate findings to a diverse audience of clinicians, bioinformaticians, statisticians, and patient advocates. Support preparation of manuscripts based on findings. Assist in planning of amendments to the EOP sub-study based on findings as needed.
The incumbent will analyze clinical, biomarker, and outcome data from the EOP, summarize findings, and draft analyses plans for new projects. The position will entail daily communication with a diverse set of stakeholders to ensure the quality and timely execution of proposed analyses. A strong background in translational biomarker research and applied bioinformatics is required. Specifically, the position will require expertise in methodologies for high dimensional biomarker association analyses with binary, continuous, and categorical outcomes, as well as for integrative analyses of biomarkers to develop predictors of endocrine response. Experience with longitudinal biomarker data analyses and visualization, next generation exome sequencing data analysis, and single-cell sequencing data analysis is preferred.
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