Sr. Associate Systems Analyst Clinical Study Design and Analysis

As a Systems Analyst at Amgen, your role involves collaborating with network and infrastructure administrators to ensure the security and maintenance of infrastructure supporting business applications. You will become a subject matter expert in Business Applications, managing regression-testing, functional, and non-functional testing for projects and enhancements. Working closely with business partners and Software-as-a-Service suppliers, you will review release notes and impact on business processes. Additionally, you will interact with developers and business analysts to elaborate technical requirements for development, enabling high-quality delivery of IT systems. Your responsibilities will include: - Supporting, monitoring, or executing installation of infrastructure security patches and configuration changes - Reviewing system release notes and identifying regression test requirements - Developing detailed test plans and strategies based on project requirements - Performing manual and automated testing of software applications - Documenting and reporting defects and issues identified during testing - Maintaining detailed documentation of test/validation plans, test cases, and results - Advising on the documentation of requirements to ensure testability - Validating test scenarios meet feature acceptance criteria and customer expectations - Ensuring the quality of documented user stories/requirements in tools such as Jira - Preparing, executing, documenting, and reporting validation protocols in line with regulatory requirements - Performing Installation Qualification, Operational Qualification, and Performance Qualification validation on processes, equipment, and systems Basic Qualifications and Experience: - Master's degree OR Bachelor's degree with 5 - 9 years of experience in Information Systems Administration/Support/Validation Functional Skills: Must-Have Skills: - Experience with GxP-regulated computer system validation - Experience with Agile software development methodologies (Scrum) - Experience with validation solutions, tools, and methodologies Good-to-Have Skills: - Experience drafting documentation in adherence to standard operating procedures - Understanding of biostatistical analysis methods - Experience with emerging technologies like generative artificial intelligence and agentic AI Professional Certifications: - Certified Tester/Agile Tester or similar (preferred) - Scaled Agile Framework (SAFe) certification (preferred) Soft Skills: - Able to work under minimal supervision - Strong verbal and written communication skills - Ability to work effectively with global, virtual teams - High degree of initiative and self-motivation - Ability to manage multiple priorities successfully - Team-oriented, with a focus on achieving team goals - Strict attention to detail and process adherence 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. Amgen is an Equal Opportunity employer and provides reasonable accommodations for individuals with disabilities. As a Systems Analyst at Amgen, your role involves collaborating with network and infrastructure administrators to ensure the security and maintenance of infrastructure supporting business applications. You will become a subject matter expert in Business Applications, managing regression-testing, functional, and non-functional testing for projects and enhancements. Working closely with business partners and Software-as-a-Service suppliers, you will review release notes and impact on business processes. Additionally, you will interact with developers and business analysts to elaborate technical requirements for development, enabling high-quality delivery of IT systems. Your responsibilities will include: - Supporting, monitoring, or executing installation of infrastructure security patches and configuration changes - Reviewing system release notes and identifying regression test requirements - Developing detailed test plans and strategies based on project requirements - Performing manual and automated testing of software applications - Documenting and reporting defects and issues identified during testing - Maintaining detailed documentation of test/validation plans, test cases, and results - Advising on the documentation of requirements to ensure testability - Validating test scenarios meet feature acceptance criteria and customer expectations - Ensuring the quality of documented user stories/requirements in tools such as Jira - Preparing, executing, documenting, and reporting validation protocols in line with regulatory requirements - Performing Installation Qualification, Operational Qualification, and Performance Qualification validation on processes, equipment, and systems Basic Qualifications and Experience: - Master's degree OR Bachelor's degree with 5 - 9 years of experience in Information Systems Administration/Sup