Statistical Computing Environments and the Practice of Statistics in the Biopharmaceutical Industry
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Alan Hopkins, PhD Senior Director. Biometrics, Theravance. Inc.. South San Francisco. California. and PharmaStat LLC. Newark. California
Susan Duke, MS, MS Associate Director. Biostatistics Development Partners, Drug Development Sciences. GlaxoSmithKline. Research Triangle Park, North Carolina
Sue Dubman, MA Senior Director. Standards and Architecture. Biomedical Data Sciences and Informatics. Genzyme Corporation. Cambridge. Massachusetts
Key Words Good statistical practice; Statistical operations; Data standards; Metadata; IT architecture; Statistical programming
Correspondrice Address Alan Hopkins, Theravance, Inc.. 901 Gateway Blvd.. South San Francisco. CA 94080 (email:
[email protected]). The Drug Information Association designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. lfyou would like to receive a statement of credit. you must review the article. and complete the posttest and evaluation included on the DIA website. Participants must receive a passing score of 80%or better on the posttest in order to receive a statement ofcredit. To access the posttest and evaluation. please visit the DIA website at www.diahome.org. select Educational Offerings. and then select Continuing Education from the drop-down menu. and the My Transcript link. This will takeyou to the My Transcript page where you will be prompted to sign in usingyour DIA username and password. Once signed in, you may select the article "Statistical
Computing Environments and the Practice of Statistics in the Biopharmaceutical Industry." You will be prompted to complete the posttest and evaluation. Upon successful completion ofthe posttest. you will be able to downloadyour statement ofcredit. If you are not a DIA customer. please contact the DIA office at [email protected] for a registration form. There is nofee to receive your statement of credit.
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Statistical Computing Environments and the Practice of Statistics in the Biopharmaceutical Industry A structured statistical computing environment (SCE) enhances rigor in opemtional implemen-
tation of statistical analyses of clinical studies t h m g h pmess transparenq, allowing reproducibility of results by independent reviewers. Desirablefeatures and associatedben4ts of an SCE system are described. Minimum SCE requirements discussed in detail consist of a stncctured programming environment, an operational analysis data repositq, and a metadata-driven architecture containing information about data and status of various processes. nte metadata provide a foundation for connecting multipleprocesses and systems,thercby dowing the creation of tods that largely automate the
analysis process. Standards drive productivity enhancement for creating statistical deliv d e s based on metadata obtained from the development plan, protocols, and analysis plans. Not all the features discussed are available today in commercial systems. In the fiture, nearly a
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