Considerations on what constitutes a ‘qualified statistician’ in regulatory guidelines-Reference-Cited by-同舟云学术

Considerations on what constitutes a ‘qualified statistician’ in regulatory guidelines

Published:2011-09-21 Issue:11-12 Volume:31 Page:1303-1305
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statist. Med.

Author:

Gerlinger Christoph¹,Edler Lutz²,Friede Tim³,Kieser Meinhard⁴,Nakas Christos T⁵,Schumacher Martin⁶,Seldrup Jørgen⁷,Victor Norbert⁸

Affiliation:

1. Bayer Pharma AG; Global Clinical Statistics; D-13342 Berlin Germany

2. German Cancer Research Center; Department of Biostatistics; Im Neuenheimer Feld 280 D-69120 Heidelberg Germany

3. University of Göttingen; Humboldtallee 32 D-37073 Göttingen Germany

4. University of Heidelberg; Institute of Medical Biometry and Informatics; Im Neuenheimer Feld 305 D-69120 Heidelberg Germany

5. Laboratory of Biometry; University of Thessaly; Fytokou Street, N. Ionia GR-384 46 Magnesia Greece

6. University Medical Center Freiburg; Institute of Medical Biometry and Medical Informatics; Stefan-Meier-Str. 26 D-79104 Freiburg Germany

7. Quintiles; Centre for Statistics in Drug Development; BP 50137, F-67404 Illkirch CEDEX France

8. President of the International Society for Clinical Biostatistics (ISCB) and University of Heidelberg; Institute of Medical Biometry and Informatics; Im Neuenheimer Feld 305 D-69120 Heidelberg Germany

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference7 articles.

1. Qualified statisticians in the European Pharma Industry: present and future directions;Williams;Drug Information Journal,2009

2. http://www.ISCB.info

3. http://www.ich.org

4. http://www.ich.org

5. http://www.rss.org.uk/uploadedfiles/userfiles/files/Prof_memb_-_CStatGradStat_notes_for_guidance_2006.pdf

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