1 of 1 CDISC Jobs in the North of England

programs, ADaM specifications, analysis (datasets, TLGs) complying with regulatory requirements, departmental SOPs and work practices. Manages and Delivers assignments with good quality and within timelines Provides programming support to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLGs. Implement programming standards and comply with regulatory requirements among … MS Office) Demonstrated ability to work independently and in a team environment. Experience Preferred: Expert level of programming skills and problem resolution in SAS. Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study/project (e.g. ISS/ISE), creation of Bioresearch Monitoring (BIMO) Inspection deliverables). Have solid knowledge of … statistical models used for efficacy data analysis. Company/Industry Related Knowledge: Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas. Core essential skill sets candidates must have to be considered for the role: Expert level of programming skills and problem resolution in SAS. Advanced knowledge of government regulations (such as More ❯