Over the past few years, the rapid increase of data from many sources and the near real time availability of these data have created a need for those knowledgeable in quantitative sciences and information technology. This, in turn, has created an increased urgency for those with quantitative and statistical skills to guide their organizations in the efficient use of statistical methods for drug development. The result is a new and evolving opportunity for statisticians to be out front and provide leadership for their organizations.

This half day course will provide a perspective on the development of leadership skills and the changing roles of statisticians in drug development. Through a combination of presentations, discussion, and personal recollections, the instructors will provide a framework for discussion of the leadership opportunity and present potential techniques that can be put into practice. The course is aimed at all statisticians working in drug development. Leadership will be broadly defined as creating a vision, setting a course, and influencing colleagues in other disciplines as well as direct line management.

Instructors:
Lisa M. LaVange
Director, Office of Biostatistics, Office of Translational Sciences, CDER
FDA, United States

Jerald S. Schindler, DrPH
Vice President, Biostatistics and Research Decision Sciences
Merck Research Laboratories, United States

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