Statistical Programmer

at  Grifols Worldwide Op Ltd

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
Provides statistical programming support to all Grifols clinical trials and supervises the statistical programming activities performed internally and externally. Provides guidance to the clinical development department in the direction of clinical data standard, Grifols statistical tables, listing, and figures standards for the medical research report and for regulatory submissions.

The duties and responsibilities include, but are not limited to, the following:

• Manages and coordinates the programming activities in clinical trials to ensure the timely completion and the quality of the analysis result presentation.
• Generates and validates statistical analyses (tables, listings, and figures) using SAS, R or other software.
• Assists in the development of data analysis plan, coordinates programming and data management process with contractors/CROs, reviews the statistical deliverables, ensures the quality of the deliverables, and acts as an integral member of a clinical project team.
• Interacts regularly with other team members within clinical development department or in other departments, preventing potential issues and/or reconciling if the issues occurred.
• Maintains overall awareness in the field of statistical programming by self-training, attending training class/conferences. Maintaining current professional knowledge in broad range of clinical research.
• Performs validation and quality review of deliverables provided by internal or external resources.
• Supports the Regulatory Affairs with electronic submission to FDA by preparing the documents under CRT folder with compliance to eCTD guidelines.
• Reviews the programming and data management related documents, e.g.. case report form (CRF) design, Annotation of CRF, edit checks, database structure.
• Acts as a lead programmer, generating/validating CDISC compliant statistical analysis database and outputs (i.e., tables, listings, figures, and inferential statistical output) using SAS, R or other software.
• Evaluates and participates in the implementation of new technologies/services, and new industrial standards (i.e. CDISC).
• Supervises and mentors other programmers (internally and externally) for their production work in statistical programming.
• Participates in the development of departmental processes, working practices, and standard operating procedures.