I am the Associate Director of Statistics at REGISTRAT-MAPI, a leader in late phase drug research, with 13 years experience in statistics (over 9 in health care). My specialty is the planning and design of clinical trials, modeling and simulation, observational studies, and weird problems. I work in strategic drug development planning, negotiate with the FDA on behalf of clients, and manage a very good group of biostatisticians and programmers.
Welcome to Statistical Consulting. I see that you have great experience in modeling, simulation and specialty designs such as adaptive methods. What is your experience with using adaptive methods when presenting the methods to the FDA? Are they open and willing to embrace these methods?
Stephan Ogenstad, PhD
President & CEO
Statogen Consulting, LLC