Principal IS Business Analyst – Clinical Study Design and Analysis

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.

Principal IS Business Analyst – Clinical Study Design and Analysis

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Principal IS Business Analyst to join the Clinical Study Design and Analysis (CSDA) product team. You will be responsible for "Run" and "Build" project portfolio execution, collaborate with business partners and other IS service leads to deliver IS capability and roadmap in support of business strategy and goals.

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 developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. 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 collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team.

Roles & Responsibilities:

• Collaborates with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals.
• Captures the voice of the customer to define business processes and product needs.
• Works with Product Managers and customers to define scope and value for new developments.
• Collaborates with Engineering and Product Management to prioritize release scopes and refine the product backlog.
• Ensures non-functional requirements are included and prioritized in the product and release backlogs.
• Facilitates the breakdown of epics into features and sprint-sized user stories and participates in backlog reviews with the development team.
• Clearly expresses features in user stories and requirements so all team members and stakeholders understand how they fit into the product backlog.
• Translates complex business and technological needs into clear, actionable requirements for development teams.
• Ensures acceptance criteria and definition of done are well-defined.
• Works closely with UX to align technical requirements, scenarios, and business process maps with user experience designs.
• Stays focused on software development to ensure it meets requirements, providing proactive feedback to stakeholders.
• Develops and executes effective product demonstrations for internal and external stakeholders.
• Maintains accurate documentation of configurations, processes, and changes.
• Serves as a liaison between global DTI functional areas and global development scientists, prioritizing their needs and expectations.
• Manages a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Life Science/Biotechnology/Pharmacology/Information Systems experience

OR

Master’s degree and 4 years of Life Science/Biotechnology/Pharmacology/Information Systems experience

OR

Bachelor’s degree and 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience

OR

Associate’s degree and 10 years of Life Science/Biotechnology/Pharmacology/Information Systems experience

OR

High school diploma / GED and 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience

Preferred Qualifications:

Must-Have Skills:

• Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery through technology.
• Experience with Agile software development methodologies (Scrum).
• Excellent communication skills and the ability to interface with senior leadership with confidence and clarity.
• Experience in writing requirements for the development of modern web applications.
• Experience in writing user requirements and acceptance criteria in Agile project management systems such as JIRA.

Good-to-Have Skills:

• Demonstrated expertise in a clinical development domain and related technology needs.
• Experience in managing product features for PI planning and developing product roadmaps and user journeys.
• Familiarity with low-code and no-code test automation software.
• Technical thought leadership.
• Ability to communicate technical or complex subject matters in business terms.
• Experience with Jira Align.
• Knowledge of cloud platforms (AWS, Azure/Databricks, GCP) and enterprise infrastructure technologies.
• Experience with DevOps, continuous integration, and continuous delivery methodologies.

Professional Certifications:

• SAFe for Teams certification (preferred).

Soft Skills:

• Able to work under minimal supervision.
• Skilled in providing oversight and mentoring team members, with a demonstrated ability to delegate work effectively.
• 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.