This document discusses the expanding role of statisticians in the biopharmaceutical industry. It notes that statisticians can provide value in all phases of clinical drug development, from pre-clinical research to data analysis and reporting results. The document advocates for statisticians to have a more prominent role earlier in the drug development process when knowledge creation is most impactful. It also highlights how statisticians are needed to properly analyze complex new data types and collaborate cross-functionally with other experts.

1. A Wider Role for Statisticians in Biopharmaceutical Industry Former Director of Indian Statistical Institute Distinguished Professor Emeritus and Advisor of C R Rao AIMSCS BIOASIA Feb 3-6, 2010, Hyderabad C. R. Rao, Sc.D., FRS __________________________________________________________________ It is to the statistician that the present age turns for what is most essential in all its important activities - R. A. Fisher

3. VISION To utilize statistical expertise in the best possible way to all areas of industry in which it will contribute to value creation __________________________________________________ Statistical knowledge is a national resource. As a knowledge based technology, it can be used without any investment in money and material anywhere to enhance performance.

5. On Tue, Jan 12, 2010, at 05:17 PM, &quot;Suryawanshi, Shailaja&quot; < [email_address] > wrote: Dear Sir, I have 2 kinds of endpoints - a continuous efficacy endpoint & a discrete safety endpoint (such as occurrence of an adverse experience). Can these data be jointly modeled to draw any inference on the risk/benefit of a drug? Are there methods to handle this - if so what are they - if not can they be developed? Thanks, Shailaja Merck& Co.Inc.,New Jersy

7. Pre - Clinical Phase Get the Statisticians more involved in the pre clinical and early clinical investigations, where value is created in terms of knowledge . Close collaboration is needed between statisticians and research workers in drug discovery.

9. Analysis of Data Analysis of data collected from clinical trials is the most difficult job of a statistician as no data set obtained from an experiment is perfect and a routine use of available software may not be appropriate. The statistician has to be in contact with the data management staff, software experts and the research staff engaged in drug discovery, devise the appropriate statistical methodology for analysis of data.

10. Statisticians, not statistics, are important The technical analysis of any large collection of data is a task of a highly trained and expensive man who knows the mathematical theory of statistics inside and out. Otherwise the outcome is likely to be a collection of drawings( produced by some software) interesting enough in a colored Sunday Supplement, but hardly the sort of thing from which to draw reliable inference. - Eric T. Bell Mathematics : Queen and Servant of Science, p.383

11. Reporting of Results This is the job of the statistician in collaboration with the research staff. The guidelines for reporting the results are available, but conveying the efficacy of the new drug and side effects in clear terms needs some experience.

12. Role and Responsibilities An advertisement for the post of a statistician by Pfizer Co The statistician will be an integral member of a systems biology team which develops and/or uses computational and statistical approaches to manage and derive knowledge of biological processes from large biological datasets (e.g., expression profiling, and other ‘omics’ sets) Teams will consist of computational biologists, geneticists, statisticians and bioinformatics specialists. These statistician positions are unique in requiring a substantial working knowledge biology. This is necessary in order to collaborate effectively with biologists in the design of appropriate experiments that will effectively elucidate the biological processes underpinning metabolic diseases

13. It pays to have statisticians on TOP and not on TAP Thank You