Amgen
Biotechnology
Sr.AssociateSystemsAnalyst–ClinicalStudyDesignandAnalysis
Neural analysis suggests this role is
optimal for Mid candidates.
“Sr. Associate Systems Analyst – Clinical Study Design and Analysis at Amgen. Skills: Clinical Study Design and Analysis, Systems Analysis, GxP-regulated computer system validation, Agile software development methodologies, Testing and Validation. Collaborate with network and infrastructure administrators in the security-patching lifecycle and maintenance of the infrastructure supporting business applications. Safeguard sensitive information and ensure the uptime, performance, and security of IT ”
Industry & Context.
This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening shifts.
What They're Looking For.
Must Have
Master's degree OR Bachelor's degree with 5 - 9 years of experience in Information Systems Administration/Support/Validation, Experience with GxP-regulated computer system validation, Experience with Agile software development methodologies (Scrum), Experience with validation solutions, tools, and methodologies
Nice to Have
Certified Tester/Agile Tester or similar (preferred), Scaled Agile Framework (SAFe) certification (preferred), Experience drafting documentation in adherence to standard operating procedures, Understanding of biostatistical analysis methods, Experience with generative artificial intelligence, agentic AI, and other emerging technologies
What You'll Do.
Collaborate with network and infrastructure administrators in the security-patching lifecycle and maintenance of the infrastructure supporting business applications
Safeguard sensitive information and ensure the uptime
and security of IT infrastructure
Become subject matter experts in Business Applications
Manage and perform routine regression-testing
as well as functional and non-functional testing for projects and enhancements
Work closely with business partners to understand business processes supported by the applications
Work closely with Software-as-a-Service suppliers to review and understand release notes and how system updates will impact business processes
Interact regularly with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and documented in a testable manner
Identify test cases and scenarios to ensure the quality and performance of IT Systems
or execute the installation of infrastructure security patches and configuration changes
Review system release notes and identify regression test requirements
Develop detailed test plans and strategies based on release notes
and specifications documents
Perform manual and automated testing of software applications
and performance testing
Document and report defects and issues identified during testing
and work with development teams to resolve them
Maintain detailed documentation of test/validation plans
Advise on the documentation of requirements to ensure that they are written in a testable manner
Validate that test scenarios meet feature acceptance criteria and customer expectations
Maintain and ensure the quality of documented user stories/requirements
and report validation protocols in line with GxP’s and other regulatory requirements and standards
Assure that all validation test procedures are in line with current technology
and governmental regulations
Perform Installation Qualification
Operational Qualification
and Performance Qualification validation on processes
How You'll Work.
Team & Collaboration
Collaborate with network and infrastructure administrators; Work closely with business partners; Work closely with Software-as-a-Service suppliers; Interact regularly with developers and business analysts; Collaborate regularly with business analysts, members of the Quality team, developers, product managers, system/network administrators, and application support team members; Work effectively with global, virtual teams
Communication Scope
verbal and written communication skills
Process & Methodology
Ability to manage multiple priorities successfully
Full Job Description
## **Career Category** Information Systems ## ## **Job Description** _ABOUT AMGEN_ Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. _ABOUT THE ROLE_ _Role Description:_ The Systems Analyst – Clinical Study Design and Analysis will collaborate with network and infrastructure administrators in the security-patching lifecycle and maintenance of the infrastructure supporting our business applications, safeguarding sensitive information and ensuring the uptime, performance, and security of IT infrastructure. In addition, the Systems Analyst will become subject matter experts in the Business Applications, and will manage and perform the routine regression-testing, as well as functional and non-functional testing for projects and enhancements. This role involves working closely with business partners to understand business processes supported by the applications, as well as working closely with Software-as-a-Service suppliers to review and understand release notes and how system updates will impact business processes. This role also interacts regularly with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and documented in a testable manner. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. This role collaborates regularly with business analysts, members of the Quality team, developers, product managers, system/network administrators, and application support team members to maintain an e
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