Principal Analyst, Statistical Programming - Ireland

About This Role:
As a Principal Analyst, Statistical Programming, you will lead and oversee the statistical programming activities both internally and externally through vendors. You will be pivotal in applying data standards, producing analysis datasets, and creating tables, listings, figures, and electronic submission components. Your collaboration with Biostatistics will ensure the delivery of high-quality, submission-ready statistical outputs. In this role, you will provide input to the Development Unit Lead on study timelines, monitor study milestones, and escalate issues as needed. As a leader, you'll guide a team of statistical programmers, ensuring effective communication and quality oversight. Representing the Statistical Programming perspective, you will be a key functional representative on study teams. Additionally, you will contribute to the implementation of the Data and Programming Strategy and collaborate on tools and process improvements.

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

What You'll Do:

• Lead and manage the timely creation and delivery of statistical programming activities and deliverables.
• Author CDISC ADaM analysis dataset specifications and work on programming endpoint algorithms.
• Manage end-to-end programming of deliverables from CRF collections through electronic submission.
• Identify process inefficiencies and lead efforts to implement improvements and train the department.
• Serve as the Statistical Programming Lead to achieve study milestones and collaborate on resource needs.
• Verify program consistency and usage of data, analysis, and submission standards.
• Inform project team members of statistical programming requirements and resource needs.

• 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.
• CDISC and/or submissions experience.
• Knowledge of drug development process and clinical trials.
• Familiarity with drug submission requirements and relevant guidelines.
• Familiarity with UNIX and software development packages, including R and AI/ML concepts.