Project Summary The goal of the Biostatistics and Bioinformatics Core (Core C) is to address the statistical design and analysis needs of the Yale SPORE in Head and Neck Cancer (YHN-SPORE) Projects, the Cores, the Developmental Research Program (DRP), and the Career Development Program (CDP). To accomplish this goal we have assembled a highly interactive team of cancer biostatisticians and bioinformaticians who will work collaboratively with basic, clinical, translational, and population science researchers to advance the frontiers of cancer medicine. The specific aims of the Biostatistics and Bioinformatics Core are: Aim 1: Provide collaboration and consulting in the design, execution, monitoring and analysis of basic, translational, population, and clinical studies for YHN-SPORE. Aim 2: Oversee and coordinate the collection, management, and analysis of data. Ensure that data collected on all YHN-SPORE studies are of high quality, are evaluated with bioinformatic and statistical rigor, are accessible within SPORE-affiliated collaborative groups, ultimately enabling the widest accessibility that is appropriate given publication and privacy concerns. For Aim 1, the Core will work closely with the investigators to analyze clinical trial and pre-clinical data, next generation sequencing data, and bioinformatics data mining. Services provided by the Core will range from planning and design activities to consulting on specific analytic questions. The Core will address the analytic and informatics questions arising from the YHN-SPORE projects. The Core will rigorously design and monitor clinical trials for safety, efficacy and futility. The Core will schedule regular meetings with the YHN-SPORE investigators, and maintain an open-door policy for any biostatistical and bioinformatics questions. The Core will conduct interim and final analyses, develop new statistical and bioinformatics methodology as needed, provide timely suggestions to YHN-SPORE investigators, and thus play an important role in the entire study. Biostatistics and Bioinformatics is also a key partner in the YHN-SPORE with representation on their Senior Leadership Team and participation in all core meetings. For Aim 2, The Core will work with the Yale Cancer Center (YCC), Yale Center for Analytical Sciences (YCAS), Fox Chase Cancer Center (FCCC) and its quantitative cores to facilitate communication among YHN-SPORE researchers, creating and implementing web-accessible databases for collecting, storing and accessing the various types of data (e.g. laboratory, clinical, population, and genomic data) that will be generated for the YHN-SPORE projects. The Core is highly integrated with the projects, and will have regular meetings with project investigators, as well as YCAS data managers, to evaluate the data generated from the studies and ensure accurate and up-to-date data management.