Grifols Shared Services North America, Inc SUMMER INTERN - Statistical Programming in Durham, North Carolina
● Generates and validates statistical analyses (tables, listings, and figures) using SAS and other software. 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 issues occur.
● Maintains overall awareness in the field of statistical programming by self-training. 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 submission documents under CRT folder with compliance to eCTD guidelines.
● May review the programming and data management related documents, e.g., case report form(CRF) design, Annotation of CRF, edit checks, database structure.
Excellent knowledge of statistical methodology, including experimental design, linear models, categorical data techniques, nonparametric statistics, and survival analysis. Knowledge of FDA guidelines related to trial design, analysis, and reporting. Solid skills in computer programming (especially SAS). Strong communication and interpersonal skills. Excellent writing ability to author reports that will be acceptable to regulatory agencies. Strong analytical, problem-solving, and active learning skills. Strong organizational, documentation, and information gathering skills. Ability to work in multiple therapeutic indications and able to handle multiple projects across these therapeutic areas.
Currently pursuing 4 year Bachelor's degree as a rising Jr or Sr, Masters or PhD with plans to return to school Fall 2021.
Must have at least 3.0 GPA
Req ID: 192447