Mgr Statistical Programming

The Manager Statistical Programming provides timely support to the study team on all programming matters according to the project strategies. Provide project leadership and programming support for processing data from clinical studies. Provides guidance in implementing and performing the programming and project standards. Lead the programming aspect of a project, both internally or CROs, for all programming results from the single study through to regulatory approval, product launch, data monitoring boards and annual reports. In this role, a typical day might include the following:

• Develop an expertise within a therapeutic area or standard tool.
• Work with minimal direction to perform, coordinate and be responsible for the preparation, execution, reporting and documentation of a project.
• Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements using Regeneron tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM)
• Manage the effort, including e-submssion results, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming results. Provide programming support for sophisticated presentations and more complex statistical ad-hoc requests.
  
  Work independently, exercise judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
• Experience in pharmaceutical clinical development in at least one therapeutic area and ability to provide programming support needs for BLA and other regulatory submissions
• Possess Advanced SAS programming skills, preferably in a clinical data environment.
• Experience in project start-up through submission.
• Knowledge in creation of current CDISC data structures.
• Strong understanding of relational databases and experience working with complex data systems.
To be considered: We seek a Bachelor's degree required. MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field preferred. 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry is also needed, including some project and/or people management