Statisticians in European regulatory agencies

The UK body of statisticians in the pharmaceutical industry, PSI, has called on heads of European regulatory agencies responsible for assessing applications for marketing authorizations for new medicines in the EU to employ full time statisticians. In order to assess the present situation a survey has been conducted to identify the number of agencies employing one or more full time statisticians. Out of 29 responding agencies, 12 employed one or more statisticians on a full time basis, whereas 17 did not. Among these 17, 7 involved external experts on a regular basis, 5 involved external statisticians on a case‐by‐case basis, whereas 5 never involved external statistical expertise. Failure to involve statisticians in the assessment of efficacy and safety of medicines does not automatically lead to reports of low quality or invalid assessment of benefit‐risk. However, in depth knowledge of statistical methodology is often necessary to uncover weaknesses and potentially biased efficacy estimates. This might be of importance for the final opinion on granting a marketing authorization, and statistical review should therefore be conducted by those who are professionally expert in the area. A positive trend toward an increased involvement of statistical expertise in the European network of regulatory agencies is observed. Copyright © 2009 John Wiley & Sons, Ltd.     

Some perspectives on statistical computing

The author argues for an increased emphasis on computing in the training of statisticians and in their professional practice. He describes some of the current technological challenges and demonstrates the importance for statisticians of becoming more active in computational aspects of their work and specifically in producing software for carrying out statistical procedures. Such a reorientation will require substantial changes in thinking, pedagogy and infrastructure; the author mentions some of the conditions required to achieve these goals.     

A course in constructing effective displays of data for pharmaceutical research personnel

Interpreting data and communicating effectively through graphs and tables are requisite skills for statisticians and non‐statisticians in the pharmaceutical industry. However, the quality of visual displays of data in the medical and pharmaceutical literature and at scientific conferences is severely lacking. We describe an interactive, workshop‐driven, 2‐day short course that we constructed for pharmaceutical research personnel to learn these skills. The examples in the course and the workshop datasets source from our professional experiences, the scientific literature, and the mass media. During the course, the participants are exposed to and gain hands‐on experience with the principles of visual and graphical perception, design, and construction of both graphic and tabular displays of quantitative and qualitative information. After completing the course, with a critical eye, the participants are able to construct, revise, critique, and interpret graphic and tabular displays according to an extensive set of guidelines. Copyright © 2013 John Wiley & Sons, Ltd.     

中国官方统计数据质量问题调查研究——基于结构方程模型

利用多个指标来分别测量官方统计数据质量及与其有关的统计人员综合水平、统计调查技术水平和统计信息利用度,在此基础上研究四者之间的关系,分析构成中国官方统计数据质量不高的成因.结果表明:统计人员综合水平、统计调查技术水平和统计信息利用度之间存在很强的相关关系;统计制度而非技术是造成当前中国官方统计数据质量不高的主要原因.     

Theory & Methods: Why do we do it? Statisticians and the Practice of Statistics

There has been no work done on why statisticians have chosen their particular profession. With the increasing emphasis on the development of biotechnology, it seems important to encourage people to take up statistics and to offer the perspective that the study of statistics brings. This paper is an attempt to develop a preliminary understanding, by open-ended in-depth interviewing, of the personal backgrounds that have encouraged present practising statisticians to move into this field, and to see how they experience their work.     

基于内部民调的地方统计数据准确性及影响因素研究

当前作为衡量经济和社会发展状况的统计数据的准确性已成为社会大众关注的焦点问题之一。以政府统计工作者为对象调查其对地方统计数据准确性及影响因素的判断,结果表明:当前中国各地统计数据质量总体比较可靠,但是一些地区统计指标的数据准确性较低,"水分"较大,领导干预是影响统计数据质量第一因素。