The incumbent provides statistical support for the development and marketing of biological products for licensing and marketing purposes in the US, Europe, and elsewhere.
Duties and Responsibilities: Duties to be performed include providing
support in the design of clinical trial studies, selection of efficacy
parameters, and planning statistical analysis strategies. The incumbent
also provides statistical consultation and guidance on
statistical problems encountered by all clinical trial professionals involved in the design of clinical trials. S/he provides SAS programming, statistical analysis supports, and evaluates mathematical methods, procedures and concepts in a variety of situations for the purpose of assessing the safety and efficacy of drug products. By written statistical analysis plans, analyzing, evaluating, interpreting, and providing both written and verbal reports of analysis results, the incumbent also advises on statistical results and their presentation, strengths and weaknesses of methods and data, validity of experimental designs used, etc. S/he must be able to render statistical judgment on any or all such projects so that they can be defended, as necessary, in special meetings with regulatory agencies.As directed by the supervisor, the incumbent may assume other responsibilities including training other clinical trial professionals with little or no statistical background on some basic statistical concepts necessary for the conduct of clinical trials
Requirements: The incumbent must possess a Ph.D. degree in statistics or related fields and have demonstrated equivalent level of expertise and professional development in accordance with the appropriate Office of Human Resources criteria. S/he will preferably have 3 + years of experience in the conduct of clinical trials using SAS working in a major pharmaceutical company. Familiarity with UNIX system and FDA and ICH guidelines preferred.