Amgen Inc.

Biostatistics Manager Thousand Oaks, CA: Ensure all statistical aspects pertaining to clinical activities meet required standards, quality and technical excellence. Conducting clinical trial study protocol including: Hypotheses, endpoints, and statistical section; statistical analysis plan; efficacy and safety monitoring plan for phase ii studies; independent data monitoring plan for phase iii studies; and clinical study report; analyzing biostatistical data based on various statistical methodologies and interpreting and presenting statistical results; utilizing statistical software such as r and sas to validate statistical analyses and enhance clinical trial design elements by simulation; utilizing Bayesian analysis to conduct simulation studies using R, SAS, winbugs/jags or facts to evaluate the operational characteristics of the design parameters; designing, analyzing and reporting clinical trials within pharmaceutical, biotechnology, or public health setting in industry, government or academia; and applying ich e9 (r1) addendum recommended strategies on estimands and choosing and defining efficacy and safety variables in clinical trial design.