Manager, Statistical Programming

As an integral part of a study, the statistical programmer provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. In this role, a typical day might include the following:

• Assist in providing mentorship in implementing and driving the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position.
• Design and test program logic, coding programs, program documentation and preparation of programs. Coordinates projects crafted to support ongoing clinical studies requests for statistical and non-statistical analyses.
• Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment.
• Support and/or lead programmer for programming and QC of analysis datasets, TFLs or standard tools following Regeneron standard data models or user requirements. Assist in the coordination of activities and communicate shifting timelines and achievements.
This role may be for you if have:
• Proficiency in the integration of data across studies in support of CSS/CSE. Build, lead and maintain the programming specifications for the analysis datasets applying Regeneron tools and methodologies.
• Support creation and validation of submission requirements (i.e. annotated CRF, data export files, define documents).
• Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports.
  
  Bachelor's in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 8+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.