Clinical Data Enablement Data Aggregation Lead

About Astellas

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.

Purpose and Scope:

The Clinical Data Enablement (CDE) Data Aggregation Lead will establish the data flow from source vendors to Astellas for Phase I-IV clinical trials executed by Astellas and transform that data for data review and cleaning purposes while also ensuring that these data are able to be shared to internal Astellas consumers following an established dataflow. 

Responsibilities and Accountabilities:

• Enable the data flow for Phase I-IV clinical trials consistent with aligned commitments inclusive of data ingest, transformation and internal availability of this data for data review, data cleaning and readiness for data analysis
• Works directly with vendors providing source data (i.e. vendors providing lab results, ECGs, biomarkers, etc.…) and/or internal functions such as clinical operations or early development to ensure that related specifications, mechanisms for data transfers and data transfer schedules are established and executed appropriately
• Contributes to related technical and/or process improvement initiatives associated with the clinical results data flow and efforts within the department and across Astellas broadly
• Collaborates with vendors providing capabilities and/or support for the clinical data flow to ensure successful delivery of study level data

•            Collaborates cross functionally with areas performing data management, clinical operations, IT support, etc. to address any issues with the delivery or stability of the clinical data flow as appropriate

Required Qualifications:

• BS, preferably in Computer Science, Informatics/Data Science, or life science discipline
• Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives
• Prior experience with systems and processes that include an end-to-end data flow and the transformation of data in support of data review and/or data cleaning
• Strong verbal and written communication skills
• Demonstrated experience collaborating with others to achieve an objective
• Familiarity with all phases of clinical development

Preferred Qualifications:

• Experience using at least one programming language (i.e., R, Python, SAS, SQL, etc…)
• Demonstrated ability and experience in leading global process or system improvement projects
• Knowledge of data standards in industry (CDISC, CDASH)

Working Environment:

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility.

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.

Our Organizational Values and Behaviors

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.