This application is for a 12-week internship role from June - August 2025. Resume review begins in January 2025. Statistical Programming (SP) is part of the R&D organization at Biogen. As a Statistical Programming intern, you will gain hands-on experience in programming and analysis processes used in clinical trials. In this role, you will learn data manipulation, analysis, and reporting of clinical trial data. This internship is designed to provide you with foundation knowledge in regulatory requirements, as well as exposure to the broader clinical trial process, all while supporting our mission of advancing medications that improve patients’ lives.This job description covers three departments within Statistical Programming looking to hire a summer intern. Their project descriptions are below.Position DescriptionAs an applicant, you will be considered for one of the following projects:Statistical Programming:  As a Statistical Programming Intern, your daily activities will be varied and hands-on, giving you exposure to many facets of the clinical trial analysis process. You will work closely with an experienced team of statistical programmers and biostatisticians and contribute directly to data analysis and reporting tasks. In this role, you will gain the following skills:SAS Programming & Data manipulation: learn and apply SAS programming techniques to clean, manipulate, and analyze clinical trial data. Work under the guidance of experienced statistical programmers to create analysis datasets and generate results.Regulatory Knowledge: gain familiarity with FDA regulations and requirements related to clinical trials such as Clinical Data Interchange standards Consortium (CDISC) standards. Learn about CDISC standards, including SDTM and ADaM, and how they apply to regulatory submissions and clinical trial reporting.Analysis Datasets & Modeling: Assist in the creation of analysis dataset (ADaM) and support statistical modeling and reporting efforts. Contribute to the development and validation of datasets required for regulatory submissions.Tabular & Graphical Representations: Help prepare clear, accurate, and comprehensive tables, listings, and figures to summarize clinical trial data. These will be used to communicate findings to stakeholders including clinical development, project management, among other team members.
 Study Data Tabulation Model Group: The SDTM group at Biogen is responsible for the transformation of all Study Clinical data into a Study Data Tabulation Model (SDTM) as required by regulatory agencies (FDA and PMDA) for any filing/approval. The group has taken initiatives using Analytics to optimize the transformation of clinical data to SDTM at various milestones in the life cycle of a clinical trial. You are:Driven with a strong aptitude for problem solving and who has strong analytical skills in various programming languages including Python with a special focus on Machine learning/NLP to optimize certain processes.As an intern with SDTM, you will work on structured data to create a database based on which a chatbot can be created to assist users and query from the database.
 Data Visualization and Application: The DV&A group seeks a summer intern who has a strong interest in improving our applications and visualization capability