Specialist Business Analyst (Life Sciences)

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. 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. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 

What you will do 

Let’s do this. Let’s change the world. In this vital role you will be responsible for leading the business analysis activities for software applications and solutions that meet business needs and ensuring the availability of critical systems & applications. This role is for a business analyst with experience around Clinical Trial Management and functional knowledge. The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with Risk based Quality Management (RBQM) domain business stakeholders, Integration engineers, Testers to ensure that the technical requirements for upcoming development are thoroughly elaborated, clearly understood & documented. 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. You will analyze business requirements and design information systems solutions. You will collaborate with multi-functional teams to understand business needs, identify system enhancements, and drive system implementation projects. Your solid experience in business analysis, system design, and project management will enable you to deliver innovative and effective technology products. You will collaborate with Product owners, developers & testers to maintain an efficient and consistent process, ensuring quality deliverables from the team. 

Roles & Responsibilities:   

• Collaborate with System Architects and Product Owners to manage business analysis activities for RBQM systems, ensuring alignment with engineering and product goals. 

• Capture the voice of the business to define business processes and product needs.  

• Collaborate with business stakeholders, Amgen Engineering teams and third-party consultants to prioritize release scopes and refine the Product backlog.  

• Support the implementation and integrations of RBQM system with other Amgen systems across different product teams. 

• Ensure non-functional requirements are also included and prioritized in the Product and Release Backlogs. 

• Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. 

• Clearly express features in User Stories/requirements so all team members and stakeholders understand how they fit into the product backlog.  

• Ensure Acceptance Criteria and Definition of Done are well-defined.  

• Stay focused on software development & implementation to ensure it meets requirements, providing proactive feedback to stakeholders. 

• Develop and execute effective product demonstrations for internal and external stakeholders. 

• Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements. 

• Identify and manage risks associated with the systems, requirement validation, and user acceptance. 

• Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users. 

• Ensure operational excellence, cybersecurity, and compliance. 

• Collaborate with geographically dispersed teams, including those in the US and other international locations. 

• Foster a culture of collaboration, innovation, and continuous improvement. 

Basic Qualifications and Experience:  

• Master’s degree with 6 - 8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR   

• Bachelor’s degree with 8 - 10 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR  

• Diploma with 10 - 13 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies  

Functional Skills:  

Must-Have Skills   

• Has experience with business systems analysis, writing user requirements and acceptance criteria in agile project management systems such as JIRA  

• Experience with Agile software development methodologies (Scrum)  

• Excellent communication skills and the ability to interface with senior leadership with confidence and clarity  

• Strong knowledge of Pharma domain/Life Sciences domain & Clinical Trial processes 

• Excellent logical and analytical skills 

• Able to communicate technical or complex subject matters in business terms 

• Familiarity with regulatory requirements for Clinical Trials (e.g. 21 CFR Part11, ICH )   

Good-to-Have Skills:  

• Experience in managing product features for PI planning and developing product roadmaps and user journeys  

• Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions  

• Knowledge of Risk based Quality Management for clinical trials 

• Technical thought leadership  

• Jira Align experience  

• Experience with data analysis, data modeling, and data visualization solutions such as Tableau and Spotfire  

• Hands on experience writing SQL using any RDBMS (Redshift, Postgres, MySQL, Teradata, Oracle, etc.)  

• Experience with AWS Services (like EC2, S3), Jira, and API gateway, etc.  

Professional Certifications (please mention if the certification is preferred or mandatory for the role):  

• SAFe for Teams certification (preferred)  

• Certified Business Analysis Professional (Preferred)  

Soft Skills (Must Have):  

• Able to work under minimal supervision  

• Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work  

• Excellent analytical and gap/fit assessment skills  

• 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  

• Strong presentation and public speaking skills  

Shift Information:   

• Candidates must be willing and able to work during evening IST hours due to overlap with PST time zone.  

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.  

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.