Analyst, Statistical Programming
$81,000–$105,000 year
Hybrid · Research Triangle Park, North Carolina, United States
Job Summary
The Analyst, Statistical Programming leads/co-leads a small study team of statistical programmers to coordinate and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects. Co-author basic CDISC ADaM analysis data set specifications including the identification of potential data issues. Works with statistics on defining programming endpoint algorithms across a study and manages end-to-end programming of deliverables from CRF collections through ESUB components. Partners with Biostatistics and Data Standards to ensure high-quality, submission-ready outputs, and contributes input to the data management timeline and study milestones. The role involves collaboration with data management and statistics on tools and process improvements for Statistical Programming, overseeing vendor quality, and serving as the statistical programming co-lead to achieve milestones. Requires strong statistical programming skills, attention to detail, and the ability to manage competing priorities while aligning with Biogen’s culture and standards.
Required Qualifications
- Bachelor’s degree required
- 2+ years relevant work experience within an organization with a focus on data management and analysis
- 2+ years SAS Base programming with 5+ years using SAS STAT, GRAPH and MACRO
- 2+ years relevant industry experience
- 2+ years clinical trial experience
- 2+ years clinical database experience
- CDISC and/or submissions experience
- Some knowledge of drug development process and clinical trials
- Some knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
- Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
- Some familiarity AI and ML concepts
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