Statistical Programmer

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 data review activities and data visualization, to collaborate on the interpretation and communication of trial results
• Contribute to regulatory submissions, converting data according to regulatory requirements, preparing integrated analyses and related documentation
• Perform post-hoc analysis for exploratory purposes, or to support regulatory requests, to prepare analysis for paper publications
• Support the development of standard operating procedures
• To convert data to CDISC SDTM, following project specifications
• Develop SAS programs to generate analysis datasets (CDISC compliant)
• Produce datasets documentation according to CDISC and FDA requirements ( and / or to review analysis datasets documentation prepared by providers
• Develop SAS programs to produce tables, listings, and figures as planned in the statistical analysis plan and to support data review activity before database lock
• Develop SAS macros and SAS programs for data quality evaluation and to develop data quality reports
• Writing, documenting, and performing quality control review of SAS programs
• Perform ad hoc analysis for various statisticians' requirements
• Support statisticians in the preparation and / or review and QC of statistical package for FDA submissions
• 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 / Standards.

Requirements :