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Kathleen S. Madsen has over 25 years in the industry of biostatistics and data management. Dr. Madsen has been Vice President of Biostatistics & Data Management at Certus International, Inc. since September 1998; from 1996 to 1998, she was Director of Biostatistics & Data Management at Certus. Dr. Madsen directs the data management, statistics and medical writing services at Certus, assists clients in clinical-plan development and protocol writing and represents clients in discussions with regulatory authorities regarding statistical issues. Prior to joining Certus, Dr. Madsen was Assistant Director of Biostatistics at Mallinckrodt Medical, Inc., where she managed and provided statistical and data management support for all clinical drug development programs, collaborated with Medical and Regulatory in clinical plan development, protocol development and preparation of study reports and communicated with FDA regarding statistical issues. In 1983, Dr. Madsen joined the newly formed pharmaceutical drug program at Monsanto Company as a Biometrics Specialist in the Health Care Division; in that position, she selected a new database management system, designed and implemented a remote data-entry system for a large multi-center trial and hired personnel for the biostatistical and data management components of the pharmaceutical program. Prior to working at Monsanto, Dr. Madsen was a Senior Biostatistician at Smith Kline and French Laboratories, where she provided statistical support in the clinical trials program, performed statistical analyses and wrote numerous study reports for New Drug Applications. Dr. Madsen also taught in the Division of Biostatistics at Washington University School of Medicine, St. Louis, Missouri, provided statistical services for medical research and performed research in statistical methodologies appropriate for analyzing data from an on-going longitudinal study in muscular dystrophy. | 