Founded in 1950, Allergan, Inc. (NYSE: AGN) is a global multi-specialty health care company headquartered in Southern California with rapidly growing annual revenues of $5+ billion. The company?s two primary segments are specialty pharmaceuticals and medical devices. Allergan's flagship franchises in eye care, neurosciences, medical dermatology and urologics, structured under Allergan Pharmaceuticals, offer specialty physicians and their patients a wide range of treatments to help preserve and protect sight, reduce physical disability and enhance quality of life. In 2006, Allergan added aesthetics and dermal fillers to its business portfolio to create a world-leading medical aesthetics franchise. At the same time, Allergan added a leading product portfolio in obesity intervention that offers minimally invasive devices to help patients achieve sustained weight loss and reduce health risks associated with obesity.
About the Position:
The Director, Biostatistics, is responsible for the activities of Biostatistics for one or multiple therapeutic areas to ensure that Allergan Medical Research and Development projects are correctly designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions and the maintenance and growth of existing products.
* Plans, organizes, and directs the activities of Biostatistics to support one or more therapeutic areas. Provides consultation with non-clinical, pre-clinical and clinical scientists regarding the conduct of experiments, clinical trials, statistical methodology, data analysis and interpretation, and regulatory issues.
* Participates in establishing and maintaining policies, standards, and guidances for global Biostatistical operations. May serve as acting head of Biostatistics when the head is absent.
* Acts as the statistical reviewer to assure and control the quality of various project and technical documents, including the review in support of license-in due diligence.
* Leads in development and adaptation of new statistical methodology in support of drug research and development. Keeps current with regulatory guidance and requirements in the global environment.
* Hires, mentors and manages employees to maintain a competent and qualified staff. Selects and hires qualified and cost-effective CRO?s to obtain optimal mixture of internal and external resources. Monitors the performance of CRO?s to ensure high quality products and services.
* Education or education/experience combination equivalent to a post graduate degree in statistics or statistics-related field. Eight (8) years of pharmaceutical experience with Ph.D. or Ph.D. equivalent.
* Four (4) years of supervisory and management experience in the pharmaceutical research environment.
* Working knowledge of non-sequential and sequential clinical trial methodologies, advanced statistical theory and methods including specific knowledge of experimental design, analysis of variance and linear models, survival analysis, categorical analysis, multivariate analysis, robust estimation, and nonparametric techniques.
* Working knowledge of at least one scientific programming language (such as FORTRAN, C/C++, Pascal) and/or at least one statistical software package (such as SAS, S-Plus, BMDP).
* Knowledge of medical device manufacturing or related field preferred.
* Knowledge of FDA regulations with regard to medical device clinical trials, preferably Class III Devices, preferred.
* Excellent analytical, problem-solving and computer skills.
* Flexible, well-organized, excellent verbal and written communication skills, and inter-personal skills.
* Works well under pressure, with initiative to take on unfamiliar tasks.
* Able to travel for business 10% of the time.