Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Cr...
Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs act...
Responsibilities: Perform data manipulation, analysis, and reporting of clinical trial data. Develop and maintain department/system-level macros. Create and review SDTM and ADaM specifications. Create and validate SDTM data sets. Crea...
Responsibilities: Develop SAS programs and statistical output for the management and reporting of clinical trial data managed by GCD . Guarantee quality of statistical output produced by external provider, to program tools to support dat...
Responsibilities: The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on market products or those products in development. Assures ...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CR...