Considerations on what constitutes a 'qualified statistician' in regulatory guidelines

Gerlinger, ChristophChristophGerlingerEdler, LutzLutzEdlerFriede, TimTimFriedeKieser, MeinhardMeinhardKieserNakas, Christos T.Christos T.NakasSchumacher, MartinMartinSchumacherSeldrup, JorgenJorgenSeldrupVictor, NorbertNorbertVictor2018-11-072018-11-072012https://resolver.sub.uni-goettingen.de/purl?gro-2/26459International regulatory guidelines require that a qualified statistician takes responsibility for the statistical aspects of a clinical trial used for drug licensing. No consensus on what constitutes a qualified statistician appears to have been developed so far. The International Society for Clinical Biostatistics is issuing this reflection paper in order to stimulate a discussion on the concept. Copyright (C) 2011 John Wiley & Sons, Ltd.Considerations on what constitutes a 'qualified statistician' in regulatory guidelinesconference_paper10.1002/sim.434521948351000304088900025