Statistician, role

Research use of analytical results in the framework of a nonanalytical setting, such as a governmental investigation into the spread of pollution here, a strict protocol might exist for the collection of samples (number, locations, time, etc.) and the interpretation of results, as provided by various consultants (biologists, regulators, lawyers, statisticians, etc.) the analytical laboratory would only play the role of a black box that transforms chemistry into numbers in the perspective of the laboratory worker, calibration, validation, quality control, and interpolation are the foremost problems. Once the reliability and plausibility of the numbers is established, the statisticians take over. 

SAS has always had and will maintain a central role in the data management, analysis, and reporting of clinical trial data. Because of the strong suite of SAS statistical procedures and the power of Base SAS programming, SAS remains a favorite of statisticians for the analysis of clinical trial data. Several companies have built their clinical trial data management and statistical analysis systems entirely with SAS software. More recently, SAS has offered SAS Drug Development as an industry solution that provides a comprehensive clinical trial analysis and reporting environment compliant with 21 CRF-Part 11. 

The statistician s role is to determine whether a disease rate of 1 in 50 is truly distinguishable from a disease rate of 0 in 50. The statistician will point out that there is only a very small chance (and chance, or probability, is what the statistician calculates) that this observed difference between the two groups of animals is actually due to the presence of the chemical in the diet of one of the groups, and its absence in the other. In fact, the statistician will state that not until the difference in disease rate is 0/50 versus 5/50 is there reasonable probability that the observed difference is actually due to the chemical. In other words, a difference in disease rate of at least 10% (0/50 versus 5/50) is necessary to achieve what is called a statistically significant effect. The difference necessary to achieve statistical significance will... 

Joiner, B.L. (1985), The Key Role of Statisticians in the Transformation of North American Industry, American Statistician, 39(3), 224-227. 

The fall of 1983 also saw the North Atlantic Treaty Organization host an Advanced Studies Institute in Cosenza, Italy, entitled Chemometrics Mathematics and Statistics in Chemistry. One hundred scientists—a most unusual collection of chemists, engineers, and statisticians from academia, industry, and government—representing a dozen countries assembled to discuss the role of sophisticated multivariate statistics in the daily routine of an analytical chemistry laboratory. 

Fraud should be contained with regular monitoring, an active QA unit and an increasing role for inspectors from the regulatory agencies. Statisticians should routinely scrutinise demographic... 

The medical statistician s role in regard to the investigation should be that of obstetrician, rather than morbid anatomist, for it is unfair to expect him to extract scientific knowledge by performing a kind of mathematical post mortem upon the numerical remains of a badly planned study. [Green FHK, Principle Medical Officer, Medical Research Council, The Lancet, 1954 ii 1084-1091.]... 

Bishop, T., Petersen, B., and Trayser, D. (1982). Another look at the statistician s role in experimental planning and design. The American Statistician, 36, 387-389. 

Even before work begins on designing a trial for the first use of a new compound in human subjects (phase 1), statisticians play a crucial role. The data derived from animal studies must be thoroughly analyzed. There must be justification of the probable safety and usefulness for the experimental use of this new drug in healthy individuals or, if warranted, in suitable patients. 

When helping to make the go or no go decisions and to select quantifiable variables for the research protocol, the statistician is truly a collaborator in clinical research and continues to do so while carrying out the role of data analyst. However, beyond these important collaborative efforts, the statistician performs yet another crucial role in the clinical research of drugs and devices. 

This chapter will attempt to elucidate the roles of statisticians and how these roles affect the overall teamwork needed to guide a new drug successfully through investigational work and to market. This chapter is not intended to provide instruction on basic or evolving statistical methods or concepts. For this kind of background information, the reader will find sources referenced in the bibliography at the end of the chapter (1,2,4). 

With greater sophistication of methods of data acquisition, intuition can play a less important role, and a bayesian philosophical approach becomes more important. In contrast to the classical approach to statistics, which is concerned with the distribution of possible measured values about a unique true value, the bayesian approach is concerned with the distribution of possible true values about the measured value at hand—a concept often greeted with hostility by traditional statisticians. 

The analysis of the data at the end of the trial is, of course, the statistician s domain. A successful analysis is one that reaches unambiguous conclusions, not necessarily the ones the clinical researcher is hoping for. As we emphasized earlier, the success of the analysis depends entirely on the way the trial was conducted and monitored, and the way the data were generated and collected. The statistician s role is to utilize the appropriate tools designed to most effectively extract the information from the data. The analysis tools do not create information. We emphasized the need to prepare for the analysis at the design stage. It is also important to think one step ahead and consider the need to analyze the... 

The statistician s role is to determine whether a disease rate of 1 in 50 is truly distinguishable from a disease rate of 0 in 50. The statistician will point out that there is only a very small chance (and chance, or probability, is what the statistician calculates) that this observed... 

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