Biostatistics Core

PROJECT SUMMARY/ABSTRACT – BIOSTATISTICS CORE The role of the Biostatistics Core is to support the investigators of the Memorial Sloan Kettering Cancer Center Pancreas SPORE in the computational and statistical aspects of their research efforts, including the design and analysis of laboratory experiments, clinical trials, molecular profiling studies, and imaging studies. Prior to the initiation of all studies, Core staff will consult with SPORE investigators to discuss the underlying scientific premise and translational goals of the project, to help the investigators select the most efficient and robust analytical methods, and to estimate sample sizes to ensure adequate power to address study objectives. In laboratory experiments, Core members will assist in the formulation of the experimental design and in the analysis and interpretation of the data at the conclusion of the study. For clinical studies, Core members will work with SPORE investigators to outline the major scientific objectives; the population to be studied; primary, secondary, and exploratory endpoints; experimental design; analysis plans; and a targeted sample size justified in probabilistic terms. At the conclusion of the trial, data analyses will be performed to assess the outcomes of the study. For molecular studies using human tissues, Core members will closely interface with the team members performing bioinformatics analysis and will have primary responsibility for merging molecular and clinical data, and for performing appropriate statistical and bioinformatics analyses. The members of the Biostatistics Core will also work with SPORE investigators to format data for publication. For imaging studies, Core members will assess the ability of different imaging modalities to localize pancreatic cancer. Imaging studies and radiomics analysis will also be employed to identify potential biomarkers of response to treatment. As the research studies proceed, Core staff will suggest modifications to the design and analysis plans as appropriate. They will also assist investigators with the preparation of any necessary graphs and tables, the interpretation of results, the preparation of presentations and manuscripts, and will consult on the design of subsequent research. If current statistical methodology does not adequately address a research question, alternative methodologies will be developed. The experienced and collaborative Biostatistics Core is well configured to provide the SPORE with a high level of statistical leadership and support that will enhance the efficiency, quality, and quantitative rigor of its science.