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

Stat Med. 2012 May 20;31(11-12):1303-5. doi: 10.1002/sim.4345. Epub 2011 Sep 21.


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.

MeSH terms

  • Biostatistics
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Clinical Trials as Topic / statistics & numerical data*
  • Humans
  • Licensure / standards
  • Licensure / statistics & numerical data
  • Practice Guidelines as Topic
  • Research Personnel*
  • Statistics as Topic / education