Profile of clinical trial biostatisticians and university courses to train them in South Africa

English: Many statistical issues in the area of clinical trials are specific to this particular field. A clinical trial biostatistician should not only be appropriately qualified in general statistical theory, but also be appropriately trained and experienced in the application of statistics to clinical trials. This thesis investigates the background and training of statisticians practicing in this field in South Africa. It provides an overview of the training that is available for clinical trial biostatisticians at universities in South Africa. Lastly, the thesis also provides recommendations for the training and development of clinical trial biostatisticians. The methodology used for this research included a literature study regarding the required profile (education/training, years of experience and part of the industry in which they are employed) of a clinical trial biostatistician, and topics of interest to such a biostatistician. A review of the content of statistics courses offered at South African Universities was performed. A questionnaire survey was conducted to assess the education/training profile of clinical trial biostatisticians in South Africa and to assess the knowledge of biostatisticians in areas considered necessary to be an appropriately qualified and experienced clinical trial biostatistician as defined in the literature. Twenty-nine respondents were considered valid clinical trial biostatisticians and were thus included in the analysis of the clinical trial biostatistician questionnaires. Twenty South African universities were approached to provide information regarding the statistics courses they present. Information was obtained from fourteen (70.0%) of these universities. The profile of clinical trial biostatisticians in South Africa, with respect to qualifications and experience, is comparable to clinical trial biostatisticians in Europe. However, the industries in which the biostatisticians are employed differ from those that employ clinical trial biostatisticians in Europe. South African clinical trial biostatisticians are not necessarily familiar with all the topics applicable to their discipline. The areas in which they were the least familiar were: regulatory requirements and international guidelines, statistical analysis considerations, reporting, and quality control and documentation. Aside from statistical methods which were mostly learned at university, knowledge and experience were mostly acquired through on-the-job training followed by self-study and reading. It is hoped that the implementation of a university programme specific to clinical trial biostatisticians, improvements in current statistical courses, the development of a clinical trial biostatistician manual and the introduction of a medical statistician certification scheme, would contribute to developing what Iman (1995) is referring to when he quotes Kettenring in saying, "Industry needs holistic statisticians who are nimble problem solvers".