Description
Responsibilities* Ensures all statistical work is processed on time to appropriate quality levels * Reviews project protocols, authors protocol statistical analysis sections, including sample size calculations or simulations * Generates and/or coordinates the creation of randomization schedules and ensures their accuracy * Reviews case report forms to ensure that protocol objectives are met and project standards are maintained * Develops statistical analysis plans for clinical trials or registry studies with fully documented table, listing, and figure shells. * Specifies statistical terms, equations for derived variables and algorithms for analysis * Prepares documentation/specifications to support SAS code for analysis programs * Understands and has the ability to use advanced statistical methods.
* Leads the analysis and reporting of results for clinical trials program or registry database, which may include ISS and ISE, annual reports and/or other regulatory documents. * Verifies statistical programs, data sets used and statistical results in regulatory documents and other reports * Develops SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays * Produces statistical reports as required