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Considerations on what constitutes a 'qualified statistician' in regulatory guidelines
Christoph Gerlinger1, Lutz Edler, Tim Friede
1Bayer Pharma AG, Global Clinical Statistics, D-13342, Berlin, Germany. Christoph.Gerlinger@bayer.com
Statistics in Medicine
|September 28, 2011
Abstract:
International 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.
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