Clinical Data Informatics Specialist

Role: Clinical Data Information Specialist, R&DX

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact

The Clinical Data Information Specialist position is an exciting opportunity to significantly contribute towards the compliance requirements of Astellas, by developing relevant and applicable data management solutions on the Regulatory data modelling platform. This role is critical for managing regulatory information utilizing IDMP requirements as a baseline. It involves building a system landscape that unlocks the potential of data, wherein a centralized repository for accurate and up-to-date regulatory information.

In close collaboration with DigitalX Pod or Value Team Captains and business leads, this role will facilitate IDMP, CMC, and other regulatory requirements through the creation, governance, and maintenance of accurate, unique, and standardized data records and models, reducing time for product approvals. The role will be responsible for defining and implementing data modeling standards, business rules, data structures, and relationships that support regulatory data domains, while fully leveraging platform capabilities and functionality to enforce data standardization, quality, and uniqueness. This will be aligned with IDMP requirements to enable interoperability and seamless data exchange across internal and external systems.

Working with a diverse range of stakeholders across Research and Development (R&D) and DigitalX, the incumbent will be involved in designing and developing solutions including Master Data Management that render a good view of how the Clinical Trial Data, and Regulatory data, including the Pharmaceutical Product master data, is connected to all systems, pre-market, and FDA/EMA approved products, ensuring a molecule to market foundational solution for regulatory compliance

• →Responsible for modelling Master Data Management (MDM) features and capabilities on Astellas enterprise platform. This role will work cross-functionally and is accountable for Business as Usual and new development activities.
• →Acts as a Subject Matter Expert in Regulatory data (e.g. product data) and associated data standards (e.g. IDMP)
• →Engages with business owners to define key business requirements and converts these requirements into data modelling and technical specifications.
• →In accordance with business requirements, develop all aspects of the solution including but not limited to Data modelling, Data Load/Export, perform complex mapping, matching and survivorship rules, data cleansing, deduplication, standardization, and data model configuration.
• →Be actively involved in testing and validation activities for all new development work. Coordinate with Foundation Data teams ensuring that Data Lakes and consuming systems reflect the accurate data.
• →Partner with Data Governance Specialists and Data Stewards to define business glossary terms, controlled terminology, metadata requirements, stewardship, quality rules, classifications, and semantic standards.
• →Map internal models to approved scientific, clinical, regulatory, and manufacturing ontologies, taxonomies, controlled vocabularies, and industry standards.
• →Participate in design and code reviews to ensure solution capabilities deliver value, in partnership with key DigitalX and business stakeholders.
• →Maintain applicable security access and privileges, mapping users’ roles with appropriate Reltio custom roles.
• →Identify use cases to harmonize data across Clinical Trial Management, and Regulatory Data ensuring tracing and tracking of data sets across Pre-commercial to Medicinal Products.
• →Actively participate in maintaining the backlog of activities, on Azure DevOps services.

• Bachelor of Science degree in Computer Science, Mathematics, Information Systems, Data Science, or a related field.
• Minimum 4 years of experience in data modeling, data architecture, and regulatory data management within the pharmaceutical, healthcare, or life sciences industry.
• Experience working with regulatory data standards and frameworks, including IDMP, CMC, Clinical, Safety, or related regulatory requirements.
• Knowledge of data governance principles, metadata management, data quality, reference data management, and business glossary development.
• Proficient in data model configuration (Entity types, attributes), matching rules, operational values and survivorship rules, relationships, User Interface, and hierarchies.
• Proficiency with enterprise data modeling tools, metadata catalogs, Databricks, Unity Catalog, Git-based version control, and modern data platforms.
• Familiarity with master data management and reference data management concepts, including data stewardship, data quality controls, matching principles, and governance processes.
• Should have an inherent desire to innovate.
• Strong knowledge of normalization, dimensional design, entity-relationship modelling, metadata management, identifiers, reference data, temporal modelling, and schema evolution.
• Experience working in an Agile methodology, distributed version control and management.
• Good experience in general purpose programming language such as Python.
• Excellent communication and interpersonal skills, enabling effective collaboration with cross-functional teams, business stakeholders, and technical experts.
• Good understanding of the SLC processes for GxP and non-GxP data environments.
• Ability to work independently, prioritize multiple assignments, and deliver high-quality outcomes

 Preferred Qualifications and Experience:

• Master’s degree in computer science or a related field
• At least 3+ years’ experience in Life Sciences industry, and an equivalent number of years in Information Technology
• Prior experience with cloud-based tools such as Veeva, Databricks, Reltio, etc.
• Experience working with Clinical data and Regulatory data (e.g. product data)
• Proficiency in SQL and data quality tools (e.g. Talend, Databricks, Informatica Data Quality).
• Strong understanding of ETL/ELT processes, and cloud based scalable data storage analytics platforms such as Azure, AWS, and GCP

 Preferred Knowledge:

• Expertise in Data Analysis, data modelling, and data integration techniques.
• Knowledge in integration solutions platforms such as Talend, Databricks.
• Knowledge of Data Lakes, Data Lakehouse, and Data Mesh architectures would be beneficial.
• In-depth understanding of life sciences product life cycle.
• Innovative problem-solving abilities for addressing complex data-related challenges.
• Project management capabilities, ensuring adherence to timelines for successful solution delivery.
• Relevant certifications in Data modelling tools are advantageous.
• Well informed on the Machine Learning trends and specifically on its application to records matching in MDM systems.
• Knowledge of regulations that regulate the Pharmaceutical Industry, specifically IDMP.
• Understanding of HL7 and FHIR data standards

 What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Values: Innovation, Integrity and Impact sit at the heart of what we do. Behaviors: We come together as ‘One Astellas, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.