Qualified Statisticians in the European Pharma Industry: Present and Future Directions
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Qualified Statisticians in the European Pharma Industry: Present and Future Directions
Z o i Williams, PhD Clinical Biometrics, LEO Phanna, Princes Risborough. UK Kit Roes, PhD Professor of Biostatistics, The Julius Center, University Medical Center, Utrecht Nigel Howitt, BSc(Hons), DipStat (Cantab), Cstat Director, Global Analysis and Reporting, P R A International, Reading, Bedshire. UK
Key Words Statistician;Pharmaceutical industry; Qualifications; Training Correspondence Address Zok' Williams, Clinical Biometrics, LEO Pharma. Longwick Road, Princes Risborough. HP27 9RR, UK (email: zoe. Williams@ leo-pharma.com).
An EFSPI Qualifications Working Party questionnaire was completed by the boards of 10 EFSPI-affiliatedorganizations. Questions concerned responsibilities,qualifications,training, continuing professional development (CPD), and professional certijication of statisticians in the Pharmaceutical industry. A master's degree in statistics was most frequently the minimum requirement for an entry-level statistician, although some companies would accept a qualification where statistics was not the primary discipline. Recent developments in statistics were considered optionalfor an entry-level statistician, which may suggest that the phar-
I NTRO D U C T l O N At present, statisticians play an acknowledged key role in drug research and development at a global level. They do so in a range of roles, either within the pharmaceutical industry or as regulators, academic researchers, or consultants. In Europe, but not necessarily only in Europe, standards of professional qualifications to meet these roles used to be unclear due to the large diversity of educational and professional career paths that could lead to the profession of statistician in drug research and development. Triggered by the International Conference on Harmonization (ICH) E 6 and E9 guidelines (1,2), a previous working party of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) established a common core definition of a 'qualified statistician" (3). Today's environment of drug development is dynamic, with a multitude of technical, political, and societal factors influencing the way new drugs can be developed and marketed for true benefit to human health. These factors have had a large impact on the roles and responsibilities of statisticians. EFSPI therefore initiated a working party to revisit and evaluate the professional standards set previously, and investigate the
maceutical statistical community is not in the best position to respond to the current changing environment. Development of statisticians by companies is well supported, although therapeutic arm and personal development courses are less well supported. Smaller counties noted there were insufficient statistical courses in their country for tmining after formal qualification. Interpretation of the ICH E9 term qualified statistician was still inconsistent five years after EFSPI published a common core definition. No EFSPI organization planned to publish a C
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