Qualified Statisticians in the European Pharma Industry: Present and Future Directions

Abstract

An EFSPI Qualifications Working Party questionnaire was completed by the boards of 10 EFSPI-affiliated organizations. Questions concerned responsibilities, qualifications, training, continuing professional development (CPD), and professional certification 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 optional for an entry-level statistician, which may suggest that the pharmaceutical 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 area and personal development courses are less well supported. Smaller countries noted there were insufficient statistical courses in their country for training 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 CPD policy or implement a registration scheme.