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If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Job Responsibility
Analysis and reporting of clinical trial data using SAS and/or R
Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
Creation and validation of complex tables, listings, and figures, both safety and efficacy
Prepare statistical programming specifications
Prepare statistical programming related documents for regulatory submissions
Maintain tracking and validation documentation
Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
Interact and collaborate with study team members from other functions globally
Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
Requirements
BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 4 years of statistical programming experience in relevant career statistical programming experience in a clinical development environment
Familiarity with drug development life cycle and excellent skills with the manipulation, analysis and reporting of complex clinical trial data
Ability to effectively perform complex statistical programming and related tasks
Ability to provide quality output and deliverables in adherence with challenging timelines
Ability to work effectively on multiple tasks or projects across therapeutic areas
Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
Working knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards with strong ability to implement the standards
In depth knowledge of SAS/STAT packages
Familiar with data quality and compliance check tools
Excellent oral and written English communication skills
Nice to have
MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming
Prior regulatory submission experience for drug approval