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Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based.
Job Responsibility
Maintain and develop re-usable software utilities for GBS and GSP
Provide technical leadership and guidance for programming teams
Oversee FSP programming team
Partner with IS to maintain and enhance GSP systems
Coordinate and collaborate with CfDA on design and implementation of statistical analysis and reporting applications
Develop and maintain departmental software utilities to support the analysis and reporting of clinical trials data
Adhere to functional standards, processes and methods across all projects
Create, maintain, and review key SDLC documents -Requirements, Operational Qualification, Installation Qualification, and Design documents
Create, maintain, and review end-user documentation (e.g., user guides, training materials)
Participate in establishing the programming scope, timeline and quality for deliverables with stakeholders
Participate in the selection of appropriate technologies and software development tools based on GSP priorities and budget
Make and ensure the implementation of high level strategic decisions, including GSP strategy for adopting newer programming (R, Python, and other)
Designated team leader responsible for project efficiency, timeliness and quality
Manage resource according to priorities
Provide technical leadership and guidance for programming team
Lead all programming-related activities on one or multiple concurrent projects
Leads and manages projects and accountable for all deliverables
Coordinate and monitor project issue reporting and resolution
Promote standard and consistent strategy and approaches to statistical programming
Provide input in the development and review of GSP SOPs and other controlled documents
Provide input into and help facilitate career development plans for all staff on assigned projects
Provide mentorship to staff
Requirements
Doctorate degree and 2 years Statistical Programming experience
Master’s degree and 6 years Statistical Programming experience
Bachelor’s degree and 8 years Statistical Programming experience
Associate’s degree and 10 years Statistical Programming experience
High school diploma and 12 years Statistical Programming experience
Nice to have
MSc or higher degree in quantitative, software engineering, or scientific subjects
8+ years of relevant statistical programming experience in a clinical development environment
Familiarity with drug development life cycle and experience in analysis of clinical trials data
Solid understanding of the latest CDISC SDTM, ADaM, and Define-XML standards
Expertise with at least one of the following programming languages (SAS, R, Python) and preferably proficiency/expertise with a second programming language (SAS, R, Python, Perl, Java, Javascript, SQL)
Experience with advanced programming capabilities (machine learning, databricks, AI for application development/code generation)
Experience with systems and application programming architectures and platforms including cloud computing, automation, ETL, and other technologies
Excellent oral and written communication skills
Prior staff development leadership and project management experience
What we offer
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits