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Job #03572

About our client Our client is a publicly owned pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. Position Location Biostatistician New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Analyze and program, tests and documents programs which create tables, listings and figures for the summarization of clinical trial data 2) Comply with ICH guidelines, applicable regulatory requirements, GCPs and SOPs 3) Assist in developing randomization schedules, sample size calculations, statistical analysis and reporting, tables, figures and listings programming 4) Provide input into the integrated clinical/statistical reports 5) Assist in creating specifications for the integration of data from multiple studies 6) Conduct programming and documentation for integrated summaries and regulatory submissions 7) Serve as the Statistical Programming Function Lead on clinical project teams 8) Follow good programming practices and adequately document programs 9) Create and maintain file structures for storing clinical data 10) Assist in protocol and CRF development Requirements 1) MS or equivalent (major in Math, Statistics or Computer Science) 2) Minimum 5 years of work experience or equivalent (biotech or pharmaceutical preferred) 3) Excellent knowledge of Oracle, SAS Macro, SAS/SQL, SAS/GRAPH and sound knowledge of SAS/STAT 4) Excellent knowledge of GCP and SOP 5) Good understanding of CDISC requirements