Core Summary The mission of the Biostatistics Core is to work with Project leaders, CEP, and DRP awardees to ensure statistical integrity in the design of their experiments and enhance rigor and reproducibility in the interpretation of their data. The development of novel statistical methodology for cancer research and the access to low-cost, fast computing have resulted in an expanded role for biostatisticians in the research process as well as a higher standard in the definition of acceptable scientific evidence. In acknowledgement of these developments, NIH has recently reiterated its long-standing commitment to rigor and reproducibility in its extramural research endeavors. Important progress has been achieved in laboratory studies, including the experimental control of both systematic and random variations as well as the integrative analysis of data sets with many variables collected at multiple time points. At the same time, methodological advances in the planning, conduct, and analysis of clinical trials have emerged rapidly and have been translated into widely accepted requirements for high quality medical investigations. Examples include sequential methods for clinical trials with time to event endpoints and statistical models for repeated measurements, and the application of such methods to complex data require highly rigorous scientific processes that can facilitate reproducibility of the analysis and inference. The Biostatistics Core will support collaborations with all SPORE investigators and leadership in order to ensure that the research studies will satisfy the prevailing and emerging scientific standards for statistical rigor. The funding requested will allow the Biostatistics Core to collaborate and consult with SPORE investigators on the design and analysis of their proposed studies using state of the art statistical and computational methods. The members of the Biostatistics Core will perform study design, write, and execute statistical analysis plans, perform data management and statistical programming, interpret the results of statistical analyses, write technical reports, generate tables and figures, and contribute to abstracts, presentations, and peer-reviewed publications. The Core members will collaborate with the other members of the SPORE study team, including the Pathology Core, to achieve the aims of the SPORE Projects. Dr Wendy B. London (3.6 calendar months) will serve as Director of the Biostatistics Core and will meet regularly with the SPORE leaders, Drs. Batchelor, Haas-Kogan, and Suva, to update them on progress of the Core, and to identify and address unmet needs.