Job TitleResponsibilities:Develop SAS programs and statistical output for the management and reporting of clinical trial data managed by GCDGuarantee quality of statistical output produced by external provider, to program tools to support data review activities and data visualization, to collaborate on the interpretation and communication of trial resultsContribute to regulatory submissions, converting data according to regulatory requirements, preparing integrated analyses and related documentationPerform post-hoc analysis for exploratory purposes, or to support regulatory requests, to prepare analysis for paper publicationsSupport the development of standard operating proceduresTo convert data to CDISC SDTM, following project specificationsDevelop SAS programs to generate analysis datasets (CDISC compliant)Produce datasets documentation according to CDISC and FDA requirements (define.xml) and/or to review analysis datasets documentation prepared by providersDevelop SAS programs to produce tables, listings, and figures as planned in the statistical analysis plan and to support data review activity before database lockDevelop SAS macros and SAS programs for data quality evaluation and to develop data quality reportsWriting, documenting, and performing quality control review of SAS programsPerform ad hoc analysis for various statisticians' requirementsSupport statisticians in the preparation and/or review and QC of statistical package for FDA submissionsPerform QC of the programming material prepared by external providers guaranteeing the output provided is correct and in line with International requirements and with internal SOP/StandardsRequirements:Bachelor's degree or higher, preferably in a scientific discipline such as Statistics, Mathematics, Computer Science, or a related applicable fieldGood experience in SASProficient in Macro FacilityExtensively involved in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to Standard Operating Procedures (SOPs)Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM), Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification (Define.xml)General knowledge of statistical methodsHave excellent analytical, problem solving, communication and interpersonal skillsEffective verbal and written communication skillsStrong commitment to qualityAbility to work in a team-based environment.