Systems Analyst Clinical Study Design and Analysis

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 efficient and consistent process, ensuring business applications maintain a reliable and validated state. 

Roles & Responsibilities:  

• Support, monitor, or execute the installation of infrastructure security patches and configuration changes, as necessary 

• Review system release notes and identify regression test requirements 

• Develop detailed test plans and strategies based on release notes, project requirements, and specifications documents 

• Perform manual and automated testing of software applications, including functional, regression, 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, test cases, and test results 

• 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 in tools such as Jira 

• Prepare, execute, document, 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, corporate, and governmental regulations 

• Perform Installation Qualification, Operational Qualification, and Performance Qualification validation on processes, equipment, and systems in conjunction with suppliers as appropriate 

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 generative artificial intelligence, agentic AI, and other emerging technologies  

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 

Shift Information:  

• 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.  

EQUAL OPPORTUNITY STATEMENT 

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.