Position Summary:
Provides statistical leadership and support for all phases of clinical development. Specific responsibilities include consulting with clients regarding clinical trial study design and regulatory strategy, writing and reviewing statistical methods and sample size sections of protocols, writing and reviewing statistical analysis plans of complex study designs, reviewing statistical analyses and presenting statistical results. Lead complex programs such as NDA/BLA/MAA submissions or complex, multi-protocol programs and provide statistical oversight. Serve as a subject matter expert for one or more areas (e.g., Bayesian adaptive study design, Survival analysis, DMC, submissions)
Essential functions of the job include but are not limited to: