Professional development of statisticians in the pharmaceutical sector: evolution over the past decade and into the future

The adoption of The International Conference on Harmonization Tripartite Guideline: Statistical Principles for Clinical Trials (ICH-E9) has provided a foundation for the application of statistical principles in clinical research and raised awareness of the value of a statistical contribution to the wider pharmaceutical R&D process. In addition, over the past decade globalization of the pharmaceutical R&D process and the measures taken to address reduced productivity and spiralling costs have impacted on the roles and career opportunities for statisticians working in the pharmaceutical sector. This has enhanced the need for continuing professional development to equip statisticians with the skills to fully contribute to creating innovative solutions. In the future, key areas of focus are the establishment of professional standards for statistical work and increasing the collaboration between statisticians working in industry, regulatory agencies and academia. In addition, the diversity of roles and potential career paths for statisticians embarking on a career in the pharmaceutical sector emphasizes the importance of mentoring and coaching. For the more experienced statisticians, there are unprecedented opportunities to lead and innovate.     

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.     

Three-Factor Cartographic Representation

Statistics and statisticians have contributed to industry. Attention has been given to the appropriate training of statisticians for careers in industry. Statistics is used with benefit to industry in quality control, experimental design in research and development, and management decisions. Statistics can benefit from industry's assistance, the subject of this article. Five premises are set forth, three of them suggesting problems for statistics and industry. They relate to public understanding of statistics, the recruitment of students to statistics, the recruitment of statisticians to industry, and the relevance of research in statistics to the needs of industry. Thirteen recommendations are made on what industry can do for statistics and suggestions are made on how the American Statistical Association and the American Society for Quality Control can provide leadership in meeting the problems posed with the help of industry.     

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.     

Who wants to be an ICH Euro billionaire?

The ICH E9 guideline on Statistical Principles for Clinical Trials is a pivotal document for statisticians in clinical research in the pharmaceutical industry guiding, as it does, statistical aspects of the planning, conduct and analysis of regulatory clinical trials. New statisticians joining the industry require a thorough and lasting understanding of the 39-page guideline. Given the amount of detail to be covered, traditional (lecture-style) training methods are largely ineffective. Directed reading, perhaps in groups, may be a helpful approach, especially if experienced staff are involved in the discussions. However, as in many training scenarios, exercise-based training is often the most effective approach to learning. In this paper, we describe several variants of a training module in ICH E9 for new statisticians, combining directed reading with a game-based exercise, which have proved to be highly effective and enjoyable for course participants.     

The Multicenter Clinical Trials Coordinating Center Statistician: “More than a Consultant”

Over the past several decades the employment of statisticians in the area of medical clinical trials in private industry, academic centers, and the federal government has increased significantly. This trend does not appear to be slowing, particularly in those organizations that have come to be termed coordinating centers. In this article we will describe the expanded role that statisticians employed in these centers are expected to be able to fill.     

It shouldn't happen to a statistician

Helen Clough and Patrick Brown are statisticians working in a cross-disciplinary veterinary epidemiology collaboration, uniting statisticians, mathematical modellers, veterinarians, molecular biologists and microbiologists. They describe the strengths that statisticians bring to the collaboration and the creative tensions that arise when both statistical and mathematical modelling techniques are used.     

Communication of statistcal concepts: examples in medical collaboration

While effective communication of statistical concepts is important for the enthusiastic adoption of these concepts by collaborators, statisticians are not necessarily trained in the process of communication with collaborators in other substantive fields. It is proposed that increased attention be paid to pedagogical techniques for communicating to our non-statistical colleagues what statisticians have to offer to the design and analysis aspects of a collaborative effort. One approach is to offer examples relevant to our colleagues’ fields when we explain statistical ideas. This paper provides several such examples from the field of neurology, focusing on the issue of sample selection bias and prospective study designs.     

In Memoriam: Simon Kuznets, 1901-1985

The profession of statistics has adopted too narrow a definition of itself. As a consequence, both statistics and statisticians play too narrow a role in policy formation and execution. Broadening that role will require statisticians to change the curriculum they use to train and develop their own professionals and what they teach nonstatisticians about statistics. Playing a proper role will require new research from statisticians that combines our skills in methods with other techniques of social scientists.     

Do statisticians count? A personal view

The number of statisticians working in the pharmaceutical industry has risen 50‐fold since the formation of PSI in 1977. It would be comforting to think that the influence of statisticians within their companies has increased in a parallel fashion, however I do not believe that to be the case. In this paper I look at barriers which prevent statisticians contributing as much as they should and look at potentials solutions. Copyright © 2002 John Wiley & Sons, Ltd.     

网络技术下统计的变革和统计教育面临的任务

网络经济的发展使现行的统计信息生产方式和统计制度发生深刻变革,使统计人才的知识结构发生重大变化,从而对统计教育的着力点和培养目标、培养方式提出了新的要求。如何培养大量优秀的复合型统计人才,极大地提高统计人员的素质,是统计教育面临的艰巨任务。     

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.     

Re-Defining the Who,When, and Where of Mentoring for Professional Statisticians

Organizations tailor their mentoring strategies to accommodate internal resources and preferences, producing different approaches in academic, government, and corporate environments. Across these settings, three common barriers impede effective mentoring of statisticians: overspecialization, time constraints, and geographic dispersion. The authors share mentoring strategies that have emerged at their organization, Mathematica Policy Research, to overcome these obstacles. Practices include creating a methodology working group to unite researchers with diverse backgrounds, integrating mentoring into existing workflows, and harnessing modern technological infrastructure to facilitate virtual mentoring. Although these strategies emerged within a specific professional context, they suggest opportunities for statisticians to expand the channels through which mentorship can occur.     

Preparing Statisticians for Careers in Industry: Report of the ASA Section on Statistical Education Committee on Training of Statisticians for Industry

This report provides guidelines for universities to consider in developing programs for training statisticians who will work in industry. Useful information for students who are considering industrial employment is also included. The recommended programs focus on real problems and the statistical theory and methodology that are useful in their solution. Technical competence is only one of many factors that industry considers when hiring and promoting statisticians. When a statistician leaves school, his or her skills and experiences should include statistical knowledge, practical problem solving, consulting practice, and the ability to communicate orally and in writing with nonstatisticians. There are many details that must be worked out (e.g., content of specific courses and organization of consulting internship programs), and it is hoped that the statistical societies and universities will form committees, hold conferences, and develop programs to address these issues further. Many of our recommendations apply more broadly to the training of all types of practicing statisticians.     

Some applications of genetics in statistical ecology

Genetic data are in widespread use in ecological research, and an understanding of this type of data and its uses and interpretations will soon be an imperative for ecological statisticians. Here, we provide an introduction to the subject, intended for statisticians who have no previous knowledge of genetics. Although there are numerous types of genetic data, we restrict attention to multilocus genotype data from microsatellite loci. We look at two application areas in wide use: investigating population structure using genetic assignment and related techniques; and using genotype data in capture–recapture studies for estimating population size and demographic parameters. In each case, we outline the conceptual framework and draw attention to both the strengths and weaknesses of existing approaches to analysis and interpretation.     

The influence function of the optimal bandwidth for kernel density estimation

Theories about the bandwidth of kernel density estimation have been well established by many statisticians. However, the influence function of the bandwidth has not been well investigated. The influence function of the optimal bandwidth that minimizes the mean integrated square error is derived and the asymptotic property of the bandwidth selectors based on the influence function is provided.     

International Statistical Activities

The growth of the health care industry places increasing strain on available resources. As in other areas of social policy, health statisticians and health data are increasingly expected to provide keys to rational decision making. To accomplish this goal, the statistician and decision-maker need to interact to an increasing degree. The current issues in health policy and the statistician's contribution to policy analysis are discussed in the context of the National Center for Health Statistics experience. While the article focuses on health, it has implications for statisticians and policy formation in other fields.     

Subgroup analyses of clinical effectiveness to support health technology assessments

Subgroup analysis is an integral part of access and reimbursement dossiers, in particular health technology assessment (HTA), and their HTA recommendations are often limited to subpopulations. HTA recommendations for subpopulations are not always clear and without controversies. In this paper, we review several HTA guidelines regarding subgroup analyses. We describe good statistical principles for subgroup analyses of clinical effectiveness to support HTAs and include case examples where HTA recommendations were given to subpopulations only. Unlike regulatory submissions, pharmaceutical statisticians in most companies have had limited involvement in the planning, design and preparation of HTA/payers submissions. We hope to change this by highlighting how pharmaceutical statisticians should contribute to payers' submissions. This includes early engagement in reimbursement strategy discussions to influence the design, analysis and interpretation of phase III randomized clinical trials as well as meta-analyses/network meta-analyses. The focus on this paper is on subgroup analyses relating to clinical effectiveness as we believe this is the first key step of statistical involvement and influence in the preparation of HTA and reimbursement submissions.     

The statistician and the computer

This paper reviews the impact of the computer on the analysis and interpretation of data. It suggests the need for professonal statisticians to recognize that almost all future analysis of data will be carried out by non-statisticians with the aid of statistical program packages. Therefore, the emphasis of statistical training for scientists, engineers, administrators and decision-makers should be on the design of data collection and the choice of appropriate methods of analysis. Both in the teaching of statistics and in the development of computer programs for statistical analysis there are important and urgent tasks to be addressed by professional statisticians.     

The professionalization of the 'shoe clerk'

Summary.  The address reviews the professionalization of statisticians working in the regulated world of drug development. The need for statisticians to continue to push the boundaries of their professional environment is stressed. It is argued that to maintain the strength and influence of the profession it is neither desirable, nor necessary, to define in a statutory sense access to the profession.