Analyst, Statistical Programming
This is a hybrid position that requires in-person weekly workdays at our offices in Durham, NC or in Cambridge, MAAbout this role The Analyst, Statistical Programming supports statistical programming activities across clinical development programs, partnering with Biostatistics, Data Management, and external vendors to deliver high-quality, submission-ready statistical outputs. This role contributes to analysis datasets, specifications, tables, listings, figures, electronic submission components, and ad hoc analyses while ensuring compliance with data and programming standards. The position also helps drive study execution, process improvement, and implementation of Biogen's data strategy. What you’ll do Co-lead, under supervision, the planning, coordination, oversight, review, completion, and delivery of statistical programming activities and study deliverables. Author and review CDISC ADaM analysis dataset specifications and identify potential data quality concerns. Collaborate with statisticians to define, document, and implement endpoint programming algorithms. Manage end-to-end programming activities from CRF collection through electronic submissions, including define.xml and XPT deliverables. Partner with submission and standards teams to ensure regulatory compliance and quality. Support continuous improvement initiatives that enhance programming processes and efficiency. Serve as the Statistical Programming co-lead for assigned studies and communicate resource needs, risks, and issues. Provide oversight and quality review of vendor programming activities and deliverables. Ensure consistent implementation of analysis, data, and submission standards across studies. Who you are You are a detail-oriented statistical programming professional with strong analytical and programming capabilities. You thrive in a collaborative environment, effectively manage competing priorities, and contribute to delivering high-quality clinical trial data and analyses. You embrace Biogen's culture of pioneering, thinking broadly, driving results, and fostering an ethical and inclusive workplace. Required skills Bachelor’s degree required and Masters preferred in Statistics, Mathematics, Computer Science or other related STEAM fields.2+ years’ relevant work experience within an organization with a focus on data management and analysis2+ years SAS Base programming using SAS STAT, GRAPH and MACRO2+ years relevant experience from industry, on clinical trial and clinical database.CDISC and/or submissions experienceSome knowledge of drug development process and clinical trials.Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)Some familiarity AI and ML conceptsPreferred skills Experience working in early phase studies (phase I, first-in-human, HV etc.)Experience from PK/PD analyses (NCA, WinNonLin,...