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  • Lead Statistical Programmer (Italia) Milan
  • IQVIA in Milan, Metropolitan City of Milan, Italy
  • jobs
  • 3 weeks ago

jobs description

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Statistical Programmer who can join an exciting working environment in a dynamic atmosphere.JOB DESCRIPTION:To develop SAS programs and statistical output for the management and reporting of clinical trial data managed by GCD. To guarantee 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 results. To contribute to regulatory submissions, converting data according to regulatory requirements, preparing integrated analyses and related documentation. To perform post-hoc analysis for exploratory purposes, or to support regulatory requests, to prepare analysis for paper publications.To support the development of standard operating proceduresRESPONSIBILITIES:To convert data to CDISC SDTM, following project specifications To develop SAS programs to generate analysis... datasets (CDISC compliant)To produce datasets documentation according to CDISC and FDA requirements (define.xml) and/or to review analysis datasets documentation prepared by providersTo develop 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 programs To perform ad hoc analysis for various statisticians’ requirementsTo support statisticians in the preparation and/or review and QC of statistical package for FDA submissionsTo perform 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 AND SKILLS:Good 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 skills Strong commitment to qualityAbility to work in a team-based environmentTYPE OF CONTRACT:Long Term contract – Staff Leasing#LI-CES #LI-DNPIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
Milan Metropolitan City of Milan Italy

salary-criteria

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