Senior Principal Analyst, Statistical Programming - Ireland

About This Role:
As a Senior Principal Analyst, Statistical Programming at Biogen, you will lead and oversee the statistical programming activities both internally and through external vendors. You will be responsible for ensuring the application of data standards and the production of high-quality analysis datasets, tables, listings, and figures. This role is pivotal in delivering submission-ready statistical outputs in partnership with Biostatistics. Your input will be crucial for planning study timelines, monitoring milestones, and liaising with Data Management counterparts. You will lead a team of statistical programmers, ensuring seamless communication and quality oversight. As a key player in implementing Data and Programming Strategy, you will collaborate closely with the Portfolio Lead to maintain statistical programming standards and drive process improvements. Your contributions will ensure that Biogen continues to set the standard in patient-focused drug development.

This role is available on a hybrid office working basis, with flexibility for remote working dependent on individual's location.

• Lead and manage the creation and delivery of statistical programming activities and deliverables for study projects.
• Serve as a statistical programming expert, authoring CDISC ADaM analysis dataset specifications.
• Oversee the end-to-end programming of deliverables, ensuring compliance with electronic submission standards.
• Identify and lead efforts to remedy process inefficiencies, training the department on new processes.
• Act as the Statistical Programming Lead to achieve program milestones, evaluating task objectives and resource needs.
• Ensure program consistency and usage of data, analysis, and submission standards across the department.
• Communicate statistical programming requirements and deliverable status to internal and external project team members.

• Bachelor's degree required, Masters or PhD in Statistics or Mathematics preferred.
• Significant and proven years of relevant work experience in the pharma/biotech industry with a focus on data management and analysis.
• Extensive years of experience in:
  
  
  • SAS Base programming, including using SAS STAT, GRAPH, and MACRO.
  • Clinical trials.
  • Clinical database experience.
• Experience with CDISC and/or submissions.
• Extensive knowledge of the drug development process and clinical trials.
• Familiarity with drug submission requirements and relevant guidelines (ICH, FDA/EMEA/ROW).
• Familiarity with UNIX, software development packages (R, Imaging, and Genomics software packages).
• Familiarity with AI and ML concepts.