The quality of medical research importantly depends, among other aspects, on a valid statistical planning of the study, analysis of the data, and reporting of the results, which is usually guaranteed by a biostatistician. However, there are several related professions next to the biostatistician, for example epidemiologists, medical informaticians and bioinformaticians. For medical experts, it is often not clear what the differences between these professions are and how the specific role of a biostatistician can be described. For physicians involved in medical research, this is problematic because false expectations often lead to frustration on both sides. Therefore, the aim of this article is to outline the tasks and responsibilities of biostatisticians in clinical trials as well as in other fields of application in medical research.

/pdf/why-do-you-need-a-biostatistician-1fswbolo0g.pdf

Why do you need a biostatistician

Biostatisticians play an important role in medical research. They are co-responsible for an appropriate and efficient study design, they are involved in monitoring the study conduct, they plan and perform the data analysis, and they are involved in interpreting and publishing the results. However, how are the biostatisticians prepared for their tasks and responsibilities? Graduate programs in biostatistics are being offered, but some practicing biostatisticians completed their studies in a mathematical or epidemiological program, or obtained their degree in subject-specific fields (such as medicine or biology). Therefore, the expertise and the competencies can vary widely between the individual biostatisticians, also depending on the application field. In this article, focusing on European and US practices, we discuss the required professional expertise for the main areas of applications in the medical field as well as the necessary soft skill competencies of a biostatistician.

What makes a biostatistician

This paper provides an overview of “Improving Design, Evaluation and Analysis of early drug development Studies” (IDEAS), a European Commission–funded network bringing together leading academic institutions and small‐ to large‐sized pharmaceutical companies to train a cohort of graduate‐level medical statisticians. The network is composed of a diverse mix of public and private sector partners spread across Europe, which will host 14 early‐stage researchers for 36 months. IDEAS training activities are composed of a well‐rounded mixture of specialist methodological components and generic transferable skills. Particular attention is paid to fostering collaborations between researchers and supervisors, which span academia and the private sector. Within this paper, we review existing medical statistics programmes (MSc and PhD) and highlight the training they provide on skills relevant to drug development. Motivated by this review and our experiences with the IDEAS project, we propose a concept for a joint, harmonised European PhD programme to train statisticians in quantitative methods for drug development.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.1873

A proposal for a new PhD level curriculum on quantitative methods for drug development.

In this article we look back over the last few decades and consider the progress made against the barriers that Andy Grieve has identified that may be holding statisticians back. We highlight some examples from his career where he leads the way in showing how we may overcome obstacles to enable statisticians to ‘count’ and assess whether anything has now changed for pharmaceutical statisticians.

Do statisticians count? A prior and posterior viewpoint

Biopharmaceutical Research, Statistics in.

Pharmaceutical statisticians have come a long way during the past 50 years in supporting product discovery, development, manufacturing, and commercialization. Statisticians are either equal partners or are consultants in all areas of pharmaceutical research and development. While statistics is enjoying a greater role in the current environment, our industry is facing unprecedented challenges. The number of approved new molecular entities has decreased in recent years. The public is expecting medicines that are more effective and have fewer side effects. Many of our customers are demanding greater data disclosure, greater transparency, and higher standards of evidence. At the same time, public trust in our industry and regulators is at its lowest point since the 1970s. To face this unfavorable external environment and to take advantage of the rapidly emerging information to drive innovations, many companies have joined forces to form collaborative partnerships. The collaborations cover not only scientific ...

/pdf/statisticians-in-the-pharmaceutical-industry-the-21st-5bxw7ew8wy.pdf

Statisticians in the Pharmaceutical Industry: The 21st Century

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Statisticians in the Pharmaceutical Industry: The 21st Century