Guidelines for Assessing the Performance of Statisticians Involved in Clinical Research in the Pharmaceutical Industry
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Dmg Information Journal. Vol. 33, pp. 4 2 7 4 3 3 . 1999 Printed in the USA. All rights reserved.
GUIDELINES FOR ASSESSING THE PERFORMANCE OF STATISTICIANS INVOLVED IN CLINICAL RESEARCH IN THE PHARMACEUTICAL INDUSTRY ALAN PHILLIPS, BSc, PHD Wyeth Research, United Kingdom, Berkshre, United Kingdom
This paper seeks to help statisticians in the pharmaceutical industry to assess their own competency, and to encourage continued development. The approach adopted is to clarify the role of statisticians in Phase II/III clinical research. Objective criteria for assessing performance in terms of qualiw, timeliness, and productivity are provided for key j o b responsibilities. A semiobjective method for obtaining an overall assessment of performance is also proposed. Key Words: Clinical development plans; Protocols; Statistical analysis; Clinical reports; Competency
INTRODUCTION CONTINUING PROFESSIONAL development is essential for the long-term success of any profession. Encouraging more e f i cient and effective performance and higher levels of achievement not only helps companies to achieve their goals but also enables individuals to fulfill their personal aspirations and achieve greater job satisfaction. For statisticians to perform well and continue their development in the pharmaceutical industry they need to know: 1. What their job is, 2. What they are expected to achieve and the standards they should maintain, and 3. How they compare against these requirements. Reprint address: Alan Phillips. BSc, PhD, Wyeth Research (UK), Huntercornbe Lane South, Taplow, Maidenhead, Berkshire, SL6 OPH, United Kingdom. E-mail: philliaQwar.wyeth.com.
Several authors such as Moses and Louis (l), Ellenberg (2), and Lesser and Parker (3) have discussed the practice of statistical consulting. As yet, however, there has been scant attention paid to clarifying the role and responsibility of the statistician in clinical research in the pharmaceutical industry, and defining criteria for assessing performance. This paper addresses both issues. The objective criteria outlined in this paper can be used as a check list to provide statisticians with feedback on how their development is progressing, and to help identify problems or factors affecting performance so that appropriate action can be taken to enhance performance. A semi-objective method for pooling information so that an overall rating of performance can be generated will also be proposed. The method increases objectivity in the evaluation of performance, encourages open communication concerning expected results, and helps individuals assess how they are progressing.
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Alan Phillips
TYPES OF STATISTICIANS IN CLINICAL RESEARCH Broadly speaking, within the pharmaceutical industry there is an accepted career path for statisticians in clinical research. Table 1 outlines the qualification and experience for the different levels. The senior statistician level is assumed to be equivalent to the C.Stat.
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