The purpose of the Biostatistics and Data Management Core for this program SPORE is to provide a comprehensive, multi-disciplinary resource for design of clinical and basic science experiments, development of appropriate and innovative statistical methodology, statistical analysis, and summary of results. The Biostatistics and Data Management Core has the following overall goals: to provide statistical consulting and collaboration on the design, conduct, analysis and interpretation of all SPORE research studies and cores, and to provide, manage and maintain a high-quality research database that supports the research projects and cores while preserving the confidentiality of all subject data.
The specific aims are: (1) Coordinate and manage statistical activities in the SPORE to ensure that investigators have ready access to statistical consultation and support. (2) Provide statistical expertise in the design of experiments and studies, including research proposal development, sample size determination, randomization procedures, and plans for interim reviews and final analysis. (3) Assist with the writing of statistical components of manuscripts. (4) Review, in conjunction with the Clinical Translational Review Committee, the integrity and statistical soundness of all studies involving human subjects. (5) Provide statistical analysis for all projects using appropriate statistical and computing methodologies, assist in the interpretation and presentation of results. (6) Interact and collaborate with the Clinical Trials and Translational Research Office in the development of protocols and the monitoring and reporting of clinical data. (7) Maintain a computing facility with up-to-date softwarefor statistical analysis to support program project investigators. (8) Conduct biostatistical methodology research on practical problems arising in cancer studies. (9) Provide computer- based tools that facilitate the storage and retrieval of the data generated in the proposed research, thereby creating and maintaining a centralized relational database that provides access to common resources and information. (10) Ensure the accuracy of the data maintained in the database by software based data consistency and quality control systems. (11) Organize and maintain the database to maximize accuracy and accessibility; while maintaining strict confidentiality. (12) Provide detailed descriptions of the available populations and resources for current and future investigators. (13) Provide high-quality data entry services.
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