Qualified Statisticians in the European Pharmaceutical Industry: Report of a European Federation of Statisticians in the
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Drug Information Journal. Vol. 33, pp. 4 0 7 4 1 5 , 1999
Printed in the USA. All rights reserved.
Copyright 0 1999 Drug Information Association Inc.
QUALIFIED STATISTICIANS IN THE EUROPEAN PHARMACEUTICAL INDUSTRY: REPORT OF A EUROPEAN FEDERATION OF STATISTICIANS IN THE PHARMACEUTICAL INDUSTRY (EFSPI) WORKING GROUP EFSPI WORKINGGROUP,*Isleworth, United Kingdom Regulatory guidelines assume that the responsibility f o r all statistical work associated with clinical trials will lie with a statistician who should be qualijed by education, training, and experience to perform this task. As diffrent European countries have widely differing educational systems and varied experiences of applying statistics in the pharmaceutical industry, it is di@xlt to develop a clear; unambiguous Europe-wide definition of the desiredprofile of such a statistician. There is a broad consensus, howevel; that an appropriate background would include a university degree in statistics or equivalent qualification, plus more than three years of experience in medical statistics. An example of an equivalent qualification would be a degree in mathematics or a related subject, involving more than one year Cfull-time equivalent) of courses in statistics. It is hoped that this outline definition will give guidance to companies, to regulatory authorities, and to individual statisticians in terms of providing statistical support to clinical trial and other pharmaceutical development activities and that it may provide a foundation for future development of the statistical profession within the pharmaceutical industry. Key Words: Regulatory affairs; Pharmaceutical industry; Statisticians; Qualifications
Reprint address: David Morgan, Director of Statistics and Data Management, M E S S Limited, John Busch House, 277 London Road, Isleworth, Middlesex T W 7 5AX United Kingdom. *The EFSPI Working Group is comprised of: David Morgan, MA, MSc, CStat, formerly Head of Biometrics and Data Management, Hoechst Marion Roussel, Denham, United Kingdom (chairman); Antonella Bacchieri, MSc. Head of Biostatistics and Data Management, Sigma-tau, Pomezia (Rome), Italy; Claus Bay, MSc. Head of Statistics and Data Management, Leo Pharmaceutical Products, Denmark; Erik C o b , MD, PhD, Lecturer in Biostatistics, Department of Statistics and Operational Research, Universitat Politecnica de Catalunya, Barcelona, Spain; Peter van Ewijk, MSc, Group Head, Biometrics, NV Organon, Oss, The Netherlands; Bemhard Huitfeldt, PhD, Director of Biostatistics and Clinical Information Systems, Astra Arcus AB, Sodertalje, Sweden; Jean-Christophe Lemarik, Dip Stat, MSc, Head of Biometrics and Data Management, Hoechst Marion Roussel, Paris, France; William Malbecq, DSc, Associate Director, Biostatistics. Merck, Sharp and Dohme (Europe), Brussels, Belgium; Willi Maurer, PhD, Head of Biostatistics Europe, Novartis Pharma AG, Basel, Switzerland; Peter Morse, BSc. Dip Stat, CStat, Head of Medical Statistics, Scotia Pharmaceuticals Ltd.. Guildford, United Kingdom; Horst Nowak, Dr Rer Nat, Head of
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