Employers, government institutions and society at large increasingly make demands on biostatisticians who design and analyse biological, medical and agricultural research. The international Guideline for Good Clinical Practice, for instance, states that pharmaceutical research should involve qualified biostatisticians. Biostatisticians working in this field are often asked to prove that they are qualified. According to the new Dutch law governing medical research on human subjects (Wet medisch-wetenschappelijk onderzoek met mensen), medical research involving human subjects must be approved by a medical-ethical examination board, which must include an expert on research methodology. The requirements regarding this expert mention a biostatistician with proven experience in medical research on humans.

Ever higher demands are also made on the statisticians involved in tests on animals and in agricultural research in general. In studies regarding the health value and safety of food and responsible development of the natural environment, the importance of statistics is increasing strongly, extending from genetics to complex questions of structuring our environment. This was recently emphasized in discussions on the dependability of complex models. Biostatistical input of recognized quality is needed here.
 
Laypersons, like many employers are, find it difficult to judge whether individuals who call themselves biostatisticians are sufficiently competent and experienced for a certain job. There is no specific training for biostatisticians in the Netherlands. There are some institutions where one can obtain a degree in statistics, but by far the largest number of working (bio-)statisticians has a different background. This situation is expected to last for the foreseeable future.
 
Against this background, the occupational group of biostatisticians increasingly feels the need for some form of registration or certification. The Dutch Society for Statistics and Operations Research (VVS) for this reason has decided to set up a register of biostatisticians. This register guarantees that a biostatistician – in the opinion of the occupational group of statisticians in the Netherlands as represented by the VVS – has sufficient theoretical knowledge and professional experience to be able to function as an independent biostatistician. It is hoped that the register will lead to a higher profile and a clearer outline of the occupational group (for its members’ benefit as well as for that of educational institutions, potential employers, government and regulating bodies), and to an adequate image in society. In establishing the registration, the VVS follows the example of countries such as the UK, New Zealand and Canada – where a register of statisticians exists already – and Germany, which has a register of biostatisticians. Registers are being set up in other countries as well.

In establishing registration requirements, we have been guided by the principle that individuals with a Master’s degree with a strong statistical and/or methodological component, as well as holders of the VVS Statistician’s Certificate, should have sufficient basic knowledge of statistics theory to be able to develop into fully skilled biostatisticians after some years of experience.

A combination of theoretical education and relevant practical experience which is extended and demonstrable is required for registration. We have thus chosen a form of registration very similar to the existing registration as a Chartered Statistician in the UK, which sums up the requirements as ‘an appropriate academic degree in statistics or a subject with a substantial coverage of statistical methods and theory, plus five years practical experience in applying statistics’.