Mgr, Biostatistics (SB)

Description Allergan Medical, a division of Allergan, Inc., offers the most comprehensive, science based portfolio of Total Facial Rejuvenation products available, including BOTOX Cosmetic; hyaluronic acid and collagen based dermal fillers; and physician dispensed skin care products. Allergan Medical also offers the industrys widest range of breast implant options for reconstructive and aesthetic breast surgery, and leading minimally invasive devices for obesity intervention treatment. Under general direction, is responsible for statistical aspects of AM clinical trials. This includes providing advice and consultation on clinical program strategy, planning statistical design of clinical trials, and applying statistical methodology to provide information for clinical research and statistical analysis. Position Requirements Masters degree (MA/MS) and four to seven years related experience; or equivalent combination of education and experience. Masters degree in Mathematics or Statistics plus four years experience as a Biostatistician preferred. Knowledge of FDAs QSR 21 CFR Part 820 and 21 CFR Part 11, ISO 9001 1994, EN 46001;1996, ISO 13485 1996, Council Directive 93/42/EEC June, 1993 (Medical Devices Directive) and the Canadian Medical Device Regulations 1998. Knowledge of FDA regulations with regard to medical device clinical trials, preferably Class III Devices; GCPs and medical device manufacturing or a related field. Knowledge of systems design and large clinical trials/biologics. Skill in assessing performance. Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts. Ability to lead and motivate others. Ability to meet deadlines; take initiative and make decisions within department/company guidelines. Ability to perform detail oriented work. Ability to plan extensively, usually affecting numerous employees and activities and requiring a significant amount of time. Ability to coordinate and synchronize multiple projects and be flexible in changing daily workload priorities. Ability to travel on business as necessary including overnight stays. Ability to maintain accuracy, consistency, and quality in a fast paced, multi task environment. Ability to guide and delegate to subordinates and analyze training needs and conduct training. Ability to administer employee discipline. Ability to demonstrate leadership in job performance by example. Ability to function in a controlled environment regulated by FDA QSRs and to handle confidential data. Ability to use statistical computer software, particularly SAS. Ability to present and discuss statistical aspects of clinical trials to professional organizations. Apply for this Job