The purpose of the Biostatistics Core is to collaborate with SPORE investigators on their research projects and to monitor the conduct of the clinical trials. Specifically, the Biostatistics Core will develop statistical designs, develop statistical analysis plans, perform data acquisition, develop databases, archive data, develop clinical research forms, perform data monitoring for clinical trials involving human subjects, perform data analysis and interpretation and aid in the development of manuscripts, abstracts and presentations. This purpose will be accomplished through the following specific aims: 1) Collaborate with SPORE investigators on study design to develop projects with appropriate statistical operating characteristics 2) Provide a statistical analysis plan for each SPORE project 3) Perform statistical analyses of project results as specified in the statistical analysis plan and collaborate with SPORE investigators on the interpretation and reporting of research findings 4) Monitor the conduct of SPORE clinical research projects to ensure patient safety and the scientific integrity of the projects 5) Collaborate with SPORE investigators on interpretation of data analysis results and aid in the development of manuscripts, abstracts and presentations. A team of two faculty and two Masters-trained biostatisticians has been assembled to meet the range of statistical methodological and analytical needs of the projects, including expertise in design and analysis of high-dimensional data and clinical trials. This team will ensure that the design and analyses are appropriate to meet the aims of the projects, which is essential to the success of the SPORE. The Biostatistics Core will be directed by Jane Meza Ph.D. and additionally staffed by Fang Yu Ph.D. (specializing in high-dimensional data analysis), Lynette Smith M.S. (Masters-trained biostatistician specializing in high-dimensional data analysis) and Robin High M.A. (Masters-trained biostatistician).
Biostatistical and computing expertise is essential to the design of laboratory-based and clinical studies because it ensures the efficient use of financial, animal and patient resources while minimizing the likelihood of false conclusions. The projects of this SPORE will generate complex data that will require substantial biostatistical and computing input to be effectively analyzed and presented.
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