The general function of the Biostatistics and Data Management Core (Core D) is to support the basic and clinical activities of the Program Project so that research studies are most efficiently designed, conducted, monitored, and analyzed. This includes data management, statistical modeling, formalization of hypotheses to be tested to ensure that valid conclusions can be drawn, design of clinical trials, and data analysis. All of these activities are carried out in collaboration with the laboratory and clinical investigators in all projects. The specific objectives are: 1. To consult and collaborate with investigators in the development of better adenoviral vectors and therapeutic gene systems; 2. To consult and collaborate with investigators on the development of imaging models to quantify the volume and intensity of gene expression in tissues and for optimizing therapeutic gene delivery; 3. To provide statistical consultation and collaboration in the planning, conducting, analyzing and reporting of Phase I/II clinical trials; 4. To coordinate project conduct and be responsible for data management and quality of clinical trials. The Biostatistics and Data Management Core will include the Senior Biostatistician as the PI for the core, a computer programmer, a data manager and two data entry clerks.
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