Sr. Biostatistician – FDA Regulatory Reporting Description:
Work with senior biostatistics and clinical development teams to design and conduct, evaluate, interpret and prepare results of clinical studies. Develop methodolody for statistical analysis and generate study randomization. Determine analysis and data presentation specifications for programmer analysts and statisticians. Perform analysis, interpret study results, collaborate with medical and biostatistics staff to produce reports, and publications. Represent the biostatistics function on project teams. Interact with FDA staff to ensure drug studies meet FDA requirements. Attend meetings with FDA on project development, collaborate with medical and biostatistics staff to produce reports for the application to the FDA. This position supports the development of various medical treatments. Requirements: Minimum requirements: are a Ph.D. in Biostatistics or closely related discipline and at least two years experience, or a Master's Degree in Biostatistics and four years experience in the support of clinical studies, preferably in a pharmaceutical industry or clinical studies unit setting. Sol id experience in statistical experimental designs and analyses, clinical trial requirements and statistical software packages such as SAS and S-PLUS. Strong interpersonal and effective communication (oral and written) skills. Pharmaceutical or closely related industry experience. Experience with Phase I - III clinical trials or studies in support of U.S. PLAs/NDAs Email resume for immediate consideration, or for further information please contact: Tom Whiting Enterprise Resource Group San Francisco, CA (voice) (415) 221-6300 (email) [EMAIL PROTECTED] ================================================================= Instructions for joining and leaving this list and remarks about the problem of INAPPROPRIATE MESSAGES are available at http://jse.stat.ncsu.edu/ =================================================================