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Bethesda North Marriott Hotel and Conference Center

Apr 07, 2014 8:30 AM - Apr 09, 2014 4:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Statistics Forum 2014

Session 7 – Leadership in a Collaborative Environment

Session Chair(s)

Joan  Buenconsejo, PhD, MPH

Joan Buenconsejo, PhD, MPH

Head of Cardiovascular and Neuroscience Biostatistics

Bristol Myers Squibb, United States

Christy  Chuang-Stein, PhD

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

Jerald Schindler, DrPH

Strategic Statistics, United States

Chief Executive Officer

Steve  Wilson, PhD

Leadership in a Collaborative “RegSci” Environment: Elements & Challenges

Steve Wilson, PhD

FDA, United States

Senior Staff Fellow, OB, OTS, CDER

Karen Lynn Price, PhD

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

Brenda Crowe, PhD

Eli Lilly and Company, United States

Associate Vice President, Statistics

Bruce  Binkowitz, PhD, MSc

The MRCT Experience

Bruce Binkowitz, PhD, MSc

Arcutis Biotherapeutics, Inc., United States

Vice President, Biometrics

Estelle  Russek-Cohen, PhD

Leadership in a Regulatory Environment

Estelle Russek-Cohen, PhD

FDA, United States

Senior Advisor, Office of Biostat

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