SUMMARY The role of the Biostatistics Core in this Program is to provide biostatistical expertise in study design, data analysis, and data management. The Core is staffed by three statisticians, and is led by Elizabeth Garrett- Mayer, PhD who has substantial experience and previous success as a P01 Core leader. Biostatisticians from this Core have worked with investigators in all Projects to optimize experimental designs, to assist with study planning including sample size justification and to perform analysis of the data resulting from experiments. Analytic plans have been developed for each Project and each aim by Core biostatisticians, which include in vitro studies, in vivo animal experiments, translational studies and clinical trials. Centralization will foster bonds and communication between Project Leaders and statistical collaborators, facilitate matching of investigators with the most appropriate statistical collaborator, and contribute to dissemination of state-of-the art analysis techniques.