Sr. Analyst, Statistical Programming - Ireland

Responsibilities

• Lead, coordinate, and manage the timely creation, oversight, and delivery of statistical programming activities and deliverables.
• Author CDISC ADaM analysis data set specifications and identify potential data issues.
• Manage end-to-end programming of deliverables from CRF collections through electronic submissions.
• Serve as the Statistical Programming Lead to achieve study milestones and collaborate on resource needs.
• Inform project team members about statistical programming requirements and deliverable status.
• Participate in remedying departmental inefficiencies and contribute to process improvements.
• Collaborate with statistics on defining and documenting endpoint algorithms.
• Ensure compliance with ESUB standards in collaboration with SMEs in SSM.

Requirements

• Required Skills:
• Bachelor's degree required, with a preference for a Master's or PhD in Statistics or Mathematics.
• Prior relevant work experience in data management and analysis.
• Strong and proven experience in SAS Base programming and experience with SAS STAT, GRAPH, and MACRO.
• Proven relevant industry experience, including clinical trial experience.
• Clinical database experience.
• Experience with CDISC and/or submissions.
• Knowledge of drug development process, clinical trials, and submission requirements.
• Familiarity with UNIX, R, Imaging and Genomics software packages, AI, and ML concepts.
• Job Level: Professional
• Why Biogen?

Benefits

Additional Information

About This Role: As a Senior Analyst, Statistical Programming, you will lead and oversee statistical programming activities both internally and via external vendors. You will be at the helm of applying data standards and producing high-quality analysis datasets, including tables, listings, figures, and electronic submission components. By partnering closely with Biostatistics, you will ensure the delivery of submission-ready statistical outputs. Your role includes providing essential input to the Programming Lead on study timelines, resource estimations, and milestone adherence. As a leader of a study team, you will communicate effectively and oversee quality, often serving as the sole functional representative from Statistical Programming. Your efforts will drive the implementation of the Data and Programming Strategy, while collaborating on process improvements and standard practice developments. This role is available on a remote working basis; candidates must be based full time in Ireland.

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