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Session 7 – Leadership in a Collaborative Environment
Session Chair(s)
Joan Buenconsejo, PhD, MPH
Head of Cardiovascular and Neuroscience Biostatistics
Bristol Myers Squibb, United States
Christy Chuang-Stein, PhD
Vice President, Head of Statistical Research and Consulting Center
Chuang-Stein Consulting, LLC, United States
With the support of professional organizations like the Drug Information Association, the American Statistical Association and the Society for Clinical Trials, statisticians involved in the development and regulation of new medical products now have many more opportunities for open scientific collaboration. To be productive and to make real progress, these collaborative efforts require high levels of volunteer effort and energy, and they must be directed and supported by effective leaders. This session will highlight the goals and accomplishments of some of these efforts, providing Forum participants an opportunity to learn from these leaders on how these groups achieved their objectives. Leaders will describe successful strategies used to manage challenges, to oversee multiple workstreams, how to seize opportunities and most importantly, how to influence without authority.
Speaker(s)
Jerald Schindler, DrPH
Strategic Statistics, United States
Chief Executive Officer
Leadership in a Collaborative “RegSci” Environment: Elements & Challenges
Steve Wilson, PhD
FDA, United States
Senior Staff Fellow, OB, OTS, CDER
DIA Bayesian Scientific Working Group
Karen Lynn Price, PhD
Eli Lilly and Company, United States
Senior Research Fellow, Statistical Innovation Center/Design Hub
Brenda Crowe, PhD
Eli Lilly and Company, United States
Associate Vice President, Statistics
The MRCT Experience
Bruce Binkowitz, PhD, MSc
Arcutis Biotherapeutics, Inc., United States
Vice President, Biometrics
Leadership in a Regulatory Environment
Estelle Russek-Cohen, PhD
FDA, United States
Senior Advisor, Office of Biostat
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