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Amgen is seeking a Biostatistical Programming Manager to join CfOR in Japan. This role supports generating RWE through hands-on programming, data management, and generating reports based upon real-world data of health care. The programming manager will partner with epidemiologists and cross-functional teams across multiple time zones to oversee request fulfillment, clarify requirements, resolve issues, and deliver high-quality outputs.
Job Responsibility:
Develop, test, validate, and execute programming code and macros that generate analysis datasets and tables, listings, and figures to support decision making in drug development
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming team and collaborate with peers in clinical and epidemiology functions
Manage all programming team activities and provide technical solutions to programming issues
Ensure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standards
Write and review programming plans and dataset specifications
Review key study-related documents including but not limited to statistical analysis plans (SAPs) and data management plans (DMPs)
Lead in the development of departmental policies and controlled documents
Respond to study and systems audits
Participate in the recruitment and oversight of programming staff
Actively participate in external professional organizations and conferences
Contribute to the continuous improvement of programming processes
Requirements:
Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics, or related field
At least six (6) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting, including postgraduate and doctoral research experience
Managerial experience directly managing people or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects
Experience in SQL, and statistical programming using SAS and R
Nice to have:
Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics, or relevant field
Track record establishing analysis standards, QC/QA processes, and controlled change management.
Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables
Foundational understanding of medical statistics (e.g., study design, hypothesis testing, propensity score methods).
Experience working with real-world healthcare data (RWD) such as NDB and DeSC
Team management
Ability to communicate confidently and effectively across cultures
Familiarity with cloud environments such as AWS, EC2, and Databricks
Proficiency in shell scripting and system operations in Linux
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