Role of the Statistician in Drug Development

Drug development in the pharmaceutical industry is a complex multidisciplinary process. To ensure appropriate statistical analyses will be performed, a statistician must be involved prior to collection of any data at every stage of the process. Due to the scrutiny of the conduct and results of the statistical analyses by regulatory authorities, it is crucial that the analyses be appropriate and correct. A review of the drug approval process and general issues associated with study design and data analysis, including examples from various therapeutic areas, will be discussed.

SPEAKER: Dr. David Bristol, is a graduate of Mathematics Department of Fredonia and is currently a statistics consultant at Monmouth, NJ.

Place: Fenton Hall, Rm. 168.

Date and Time: October 5, 4 pm

Sponsored by: Mathematics Department and MACS Scholarship Program