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

, : Considerations on what constitutes a 'qualified statistician' in regulatory guidelines. Statistics in Medicine 31(11-12): 1303-1305

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.


PMID: 21948351

DOI: 10.1002/sim.4345

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