title: Considerations on what constitutes a 'qualified statistician' in regulatory guidelines.
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.
authors.affiliation: Bayer Pharma AG, Global Clinical Statistics, D-13342, Berlin, Germany. Christoph.Gerlinger@bayer.com
authors.forename: Christoph
authors.initials: C
authors.lastname: Gerlinger
authors.forename: Lutz
authors.initials: L
authors.lastname: Edler
authors.forename: Tim
authors.initials: T
authors.lastname: Friede
authors.forename: Meinhard
authors.initials: M
authors.lastname: Kieser
authors.forename: Christos T
authors.initials: CT
authors.lastname: Nakas
authors.forename: Martin
authors.initials: M
authors.lastname: Schumacher
authors.forename: Jørgen
authors.initials: J
authors.lastname: Seldrup
authors.forename: Norbert
authors.initials: N
authors.lastname: Victor
mesh_terms: D056808:Biostatistics; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D006801:Humans; D008004:Licensure / Q000592:standards / Q000706:statistics & numerical data; D017410:Practice Guidelines as Topic; D012108:Research Personnel; D013223:Statistics as Topic / Q000193:education