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WHAT
IN
Manager Biostatistics
Job
Allergan
US
-
Irvine,
California
Job Code - 090728
Position - See job description
Job First Active on: Sunday, November 01, 2009
APPLY TO THIS JOB (You will be applying directly to Allergan for this position!)
JOB DESCRIPTION: Manager, Biostatistics
Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs - and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers.
As the project statistician for assigned clinical programs, the position represents BDMP on project teams advising team members in drug development strategies, plans all aspects of data analysis for assigned projects, has responsibility for the preparation and maintenance of the Analysis Plan (AP), and ensures the quality controlled production of all tables, listings and graphs for the clinical document while adhering to the pre-specified analyses and timelines. This position interacts with domestic and foreign regulatory agencies for Allergan R&D projects. The position may serve on company and/or departmental teams and make recommendations for departmental standards.
REQUIREMENTS - QUALIFICATIONS: Manager, Biostatistics
* Education or education/experience combination equivalent to a post graduate degree in statistics or statistics related field. At least six (6) years of pharmaceutical experience with a Ph.D. or Ph.D. equivalent. At least eight (8) years of pharmaceutical experience with a master's degree or master's degree equivalent. * Statistical expertise with regard to clinical studies Design: cross over, multiplicity, interim analyses, non inferiority, sample size and power * Statistical expertise with regard to clinical studies Analysis: treatment by center interaction, multi center, missing value imputation, covariate, and subpopulations * Statistical expertise with regard to clinical studies Methodology: analysis of variance and mixed linear models, survival analysis, categorical data analysis, reliability, multivariate analysis, robust estimation, nonparametric techniques, and group sequential analyses * Solid knowledge in global regulatory guidance documents and requirements * Working knowledge of SAS * Excellent oral and written communication skills * Excellent interpersonal skills * Excellent analytical, problem solving, and computer skills * Flexible and well-organized with the initiative to take on unfamiliar tasks and work well under pressure
EEO/AA M/F/V/D
Allergan
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