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

• Bachelor's degree or higher, preferably in a scientific discipline such as Statistics, Mathematics, Computer Science, or a related applicable field
• Good experience in SAS
• Proficient in Macro Facility
• Extensively 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 methods
• Have excellent analytical, problem solving, communication and interpersonal skills
• Effective verbal and written communication skills
• Strong commitment to quality
• Ability to work in a team-based environment.