Job Description

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 remote working basis; candidates must be based full time in Ireland.

What You’ll Do:

• 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.
  

Who You Are:
You have honed your expertise in statistical programming and enjoy leading and collaborating across functions. Your attention to detail and ability to manage competing priorities are well-developed. You embody Biogen's culture essentials, including pioneering, thinking broadly, driving results, and maintaining ethical and inclusive practices.

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?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.