Director, Statistics

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.
Responsible for leading and directing the statistical aspects/strategy for one or more therapeutic areas. Each group will consist of six to twelve Ph.D. and M.S. level statisticians who work as a team to provide statistical support to the therapeutic areas. The Director, Statistics is responsible for providing scientific input to project plans, for strategic decision-making on statistical issues pertaining to the plan, for assuring that the projects' clinical programs incorporate sufficient statistical and scientific rigor and quality to meet stated objectives and global regulatory needs, and for ensuring that these plans are carried out. This individual will provide expert statistical and scientific recommendations in support of ongoing projects in the Global Project Teams. The Director, Statistics is responsible for ensuring that scientific expertise and technologies available are properly integrated to accomplish project goals. Negotiates with FDA reviewers, or their global counterparts, to obtain resolution of issues/questions from worldwide regulatory agencies. Demonstrates an accurate understanding and implementation of current regulatory requirements and issues that could affect the design, conduct, analysis, or interpretation of clinical programs. Responsible for allocating resources within the group, including accurate prediction of future workloads and the ability to maximize statistical productivity within the group, as well as, work effectively with the programming group. The Director has budgetary responsibility for the group, and is responsible for recruiting high caliber statisticians to the department. The Director is also responsible for providing strong professional and technical leadership to maintain a highly motivated staff.Qualifications
A minimum of 10+ yrs experience in pharmaceutical development and applied statistics/statistical consulting. Experience leading at least two of the following: NDA, BLA, and/or CTD submissions.
A minimum of 3 yrs supervisory experienceHigh degree of technical competence and communicative ability, both oral and written. Highly competent in experimental design, descriptive and inferential statistics, and computer systems, especially in medical applications. Pharmaceutical or related industry experience with clinical trials, including interaction with regulatory agencies, especially, FDA.Knowledge of the guidelines of worldwide regulatory agencies; the ability to lead and advise the Global Project Teams and other scientists in the methodology and design of clinical studies.
M.S./Ph.D. degree in statistics, biostatistics, biometrics, or a related field preferred and/or required.

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REQUIREMENTS
Please see Job Description