Specialist IS Business System Analyst

The Amgen India Digital Technology & Innovation Specialist IS Business System Analyst for Clinical Data Hub will be responsible for performing business analysis, solution design and application ownership for the Clinical Data & Analytics Clinical Data Hub that is built for delivering high-end and innovative technologies.

This role requires expertise in Clinical domain, requirements elaboration, solution design and technology evaluation/assessment, managing teams both from Build and DevOps/Sustainability perspective. Additionally, extensive collaboration with global teams is required to ensure seamless integration and operational excellence.

The ideal candidate will have a strong background in the end-to-end software development lifecycle and be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure.

As Specialist IS Business Analyst of CT Insights in R&DI, you will be working closely with the Product Owner / Business teams and collaborate with statisticians, data scientists, data engineers, AI/ ML engineers for the Business & Technical requirements, engage in design & development and end-to-end implementation as part of Build and DevOps & Sustainability. In this role, you will perform requirements analysis, engage in solution approach/design, prioritize requirements and manage the team.

You will also serve as a liaison to collaborate with multi-functional teams to understand business needs, identify system enhancements, and drive system implementation projects

• Lead and manage large, diverse teams within a matrixed organization.
• Collaborate with geographically dispersed vendor teams / external business partners, including those in the US and other international locations from implementation and contractual needs
• Oversee the software development lifecycle for Clinical Data Hub.
• Partner and ensure alignment of the Amgen India DTI site leadership and follow global standards and practices.
• Foster a culture of collaboration, innovation, and continuous improvement.
• Maintains in-depth knowledge of clinical development business domains with an emphasis in the Clinical Patient Study Data CDISC data models, data pipelines, Clinical Design & Analysis as well as an understanding of the multi-functional dependencies
• Serve as BA to work with product owner and business and DTI team members to continuously build and implement Clinical Patient Data platform (clinical patient data storage and process, data security and governances, structured SDTM and ADaM clinical data harmonization) to support Amgen global development and Precision Medicine initiatives
• Systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business need
• Technology Evaluation to evaluate and adopt groundbreaking AI/ ML and cloud technologies to address clinical development business needs. Contribute to shaping the vision and roadmap for the R&D software ecosystem
• Serve as a liaison between across DTI functional areas and R&DI Business teams on understanding the Business priorities, needs and expectations
• Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and milestones
• Identify and manage risks associated with the systems, including implementation and technological risks, and user acceptance

• Masters degree with 4 - 6 years of experience in Computer Science, IT or related field (OR)
• Bachelors degree with 6 - 8 years of experience in Computer Science, IT or related field (OR)
• Diploma with 10 - 12 years of experience in Computer Science, IT or related field

Must Have Skills:

• Extensive experience in the software development lifecycle.
• Excellent collaboration and communication skills to collaborate with Business teams, data scientists and data engineers to deliver functional business requirements as well defining product roadmap
• A solid foundation in modern software design and engineering practices and business analysis.
• Demonstrable experience in understanding and gathering business requirements and deliver actionable insights, and driving tangible business outcomes
• Technical Proficiency: Good understanding of the following technologies: Python, R, AI/ML frameworks, relational databases/data modeling, AWS services (EC2, S3, Lambda, ECS, IAM), Docker and CI/CD/Gitlab, Apache/Databricks, Frontend / Visualization technology
• Solid understanding and experience of clinical development process within Life Sciences (global clinical trial data sources, SDTM & ADaM, end-to-end clinical data design and analysis pipeline, clinical data security and governance)
• High learning agility demonstrated ability of quickly grasp ever changing technology and clinical development domain knowledge and applied to the project work

Good to Have Skills:

• Work experience in the biotechnology or pharmaceutical industry.
• Familiarity with GxP standards.
• Experience using and adopting Scaled Agile Framework (SAFe)
• Strong problem-solving and analytical skills.
• Ability to work effectively in a fast-paced, dynamic environment.

Certification:

• SAFe for Teams certification (preferred)

Soft Skills:

• Strong communications skills in writing, speaking, presenting and time management skills
• Strong transformation and change management experience.
• Exceptional collaboration and communication skills.
• 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.