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 (define.xml) 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 :