Astellas Canada – Clinical Data Architect & Engineer
At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
About Us:
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.
Astellas Pharma Canada (APCA) is currently searching for a Clinical Data Architect & Engineer reporting to Lead, Clinical Data Management, FoundationX.
Description
The Clinical Data Architect and Engineer role serves the purpose of fostering innovation and operational efficiency through the facilitation of data-driven decision-making processes, expediting drug discovery initiatives, and bolstering regulatory compliance efforts. This role involves designing and implementing customized data architecture solutions tailored to the complexities of life sciences research and development. It also includes supervising the integration and management of various data sources, such as clinical trials data, operational data, genomic data, and real-world evidence.
Through close collaboration with research scientists, statisticians, clinicians, regulatory experts, and DigitalX professionals, this role establishes and upholds robust data architecture frameworks that align harmoniously with business objectives, regulatory mandates, and industry standards. Expertise in Data Engineering, Data Modeling, Business Intelligence (BI) technologies, and adeptly managing governance processes is essential for maintaining the integrity, security, and accessibility of data assets. This role holds a strategic position in advancing the life sciences company's mission by using data to drive scientific progress, improve patient outcomes, and efficiently and securely introduce ground-breaking therapies to the market.
Essential Job Duties
Develop and maintain comprehensive data architecture strategies tailored to the unique needs of Clinical and Operational data management. Design scalable, efficient, and secure databases, data warehouses, and data lakes to store and manage clinical data effectively. Define and implement data models, schemas, and integration frameworks to ensure the integrity and accessibility of clinical data. Lead all data engineering tasks and implement data pipelines, ETL processes to ingest, transform, and load clinical data from various sources into the data infrastructure. Optimize data workflows and performance through automation, parallel processing, and data partitioning techniques. Collaborate with data scientists and analysts to support advanced analytics, machine learning, and predictive modeling initiatives. Integrate disparate clinical systems, applications, and data sources to enable interoperability and data exchange across the life sciences ecosystem. Develop APIs, interfaces, and middleware solutions for seamless communication between clinical software systems and databases. Ensure compatibility and compliance with industry standards such as HL7, FHIR, and others. Implement security controls, encryption mechanisms, and access management policies to protect sensitive data from unauthorized access, breaches, and cyber threats. Monitor compliance with healthcare regulations such as HIPAA, GDPR, and other data privacy laws, and implement measures to address potential risks and vulnerabilities. Conduct performance tuning and optimization of databases, queries, and data processing pipelines to enhance efficiency, reliability, and scalability. Monitor system health, data integrity, and performance metrics using monitoring tools and implement proactive measures to address issues and bottlenecks. Document data architecture designs, technical specifications, and operational procedures to facilitate knowledge transfer and support ongoing maintenance and enhancements. Provide guidance, training, and mentorship to team members and stakeholders on best practices in data management, architecture, and engineering. Work closely with cross-functional teams including statisticians, statistical programmers, researchers, DigitalX members, and regulatory experts to understand requirements and priorities for clinical data management and analysis. Communicate effectively with stakeholders to ensure alignment of data architecture and engineering solutions with organizational goals and objectives. Stay abreast of emerging technologies, trends, and best practices in clinical data management, architecture, and engineering. Identify opportunities for process improvement, automation, and innovation to enhance the efficiency and effectiveness of data management practices.