Professional of the Year - Pharmaceutical/Biostatistics

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Margaret C. Minkwitz

Title: Statistical Science Director
Industry: Pharmaceuticals
Type of Organization: Pharmaceutical Company, Research and Development of Prescription Drugs
Major Product/Service: Nexium®, Crestor®, Seroquel®, Arimidex®, Rhinocort®, Accolate®, Zomig®
Expertise: Dr. Minkwitz specializes in biostatistics, project management and management.
Geographic Area of Distribution: International
Affiliations: Section Representative, Biopharm Section, American Statistical Association; Past President, International Biometrics Society; Past President, Delaware Chapter of the American Statistical Association; Secretary, Caucus for Women in Statistics; Elected to Council of Sanctions, Biopharmaceutical Council
University/Degree: A.A.S., Mathematics and Science, Corning Community College, New York, 1966; B.S., Biology and Mathematics, 1980, Elmira College, New York; M.S., Biostatistics, 1983; Ph.D., Biostatistics, 1986; Cornell University, New York
Born: June 30, 1946, Corning, New York
Hobbies/Sports: Singing with the AstraZeneca Singers and the St. Mary of the Assumption Adult Choir, playing handbells in the St. Mary of the Assumption Handbell Choir, sewing, knitting, needlework
Spouse: Vernon C. Minkwitz
Married: September, 1990
Children: Catherine Flavin, Richard Cecce, Leanna Williams, Florence Smith; Ten grandchildren
Work History: Dr. Minkwitz began her career in pharmaceuticals as a Biostatistician at Dupont. She worked as a Biostatistics Team Leader ICI and an Associate Director in Medical Affairs, both at AstraZeneca. She then became the Director of Statistical Science Neuroscience Products at AstraZeneca where her responsibilities included ensuring statistical resources were available to provide statistical input for clinical trials (protocol development through reporting), regulatory agency interactions and publications. Dr. Minkwitz is currently a Technical Standards Delivery Leader responsible for developing Global Standard Operating Procedures for Clinical Development and working on process improvement projects along with continued support for Neuroscience projects.
Published Works: Dr. Minkwitz is the co-author of 15 articles in various medical journals for Accolate®, 10 for Merrem® and 10 for Seroquel®.
Career Accomplishments: Dr. Minkwitz was responsible for statistical support of the U.S. marketing approval for Accolate® including participation in the FDA advisory panel in 1996. She provided statistical support for U.S. marketing approval for bi-polar depression indication for Seroquel® in 2006 and internationally from 2008 to 2009 .