Lyell is looking for a Senior Clinical Data Architect to join the Information Sciences team, and lead the data architecture and modeling of Lyell’s cloud Clinical Data Platform to support its upcoming clinical trials. This role represents an opportunity to work closely with Lyell’s Clinical Data Platform Product Manager, Software Engineering team, and Clinical team to build a Clinical Data Platform from the ground up.
The Clinical Data Platform will be required to automate daily exchanges with Lyell’s clinical CRO, serve as a centralized data store (single source of truth), provide strict access control to data, enable biostatistics analytics, monitoring and analytics dashboards, and eventually enable predictive modeling and correlative studies. In addition, one of the key differentiators for this platform will be to link clinical data with CMC (manufacturing) data to provide insights into the manufacturing of Lyell’s cell therapies, and link this information to patient outcomes. The platform will be built on AWS, and will leverage the foundational data lake, data pipelines, and analytics infrastructure that the Information Sciences software engineering team has built. You will be able to work with Lyell’s top notch in-house team of data, analytics, frontend, backend, and DevOps engineers.
We are looking for a very experienced Data Architect that has a deep experience working with clinical trial data systems, and has a track record of working with business, technology, and clinical teams to build software solutions that are data and analytics focused. We are looking for people who are passionate about data and how data can help improve patient outcomes! This role can be based out of California or Washington, remotely.
KEY ROLE AND RESPONSIBILITIES:
- Design the Clinical Data Platform data architecture and data model
- Help define the roadmap for the Clinical Data Platform
- Work collaboratively in cross-functional groups, such as software engineering, product management, UX, clinical, and manufacturing
- Deep experience with clinical systems and data, preferably in biotech/pharma context
- Clinical systems including EDC, eTMF, CTMS, etc.
- Clinical data standards (CDISC, CDASH, SDTM, ADaM, HL7/FHIR)
- Designing enterprise data models and architecture spanning multiple systems
- Designing data pipelines for automated data acquisition and transformations
- Designing data integration across multiple systems
- Demonstrated leadership skills, including presentations and communication to stakeholders
- Strong experience with AWS technologies (ex: S3, Lambda, Glue, Athena, Docker, etc.)
- Managing data on S3 data lakes, SQL data warehouses, or NoSQL systems; must have SQL experience
- Python experience, and ability to build prototypes
- Experience designing and building applications requiring compliance (HIPAA, 21 CFR part 11)
- Degree (B.S., M.S. or PhD) in Computer Science, Math, Physics, or biological sciences is preferred, but not required
PREFERRED ADDITIONAL SKILLS:
- Experience with business intelligence (BI) tools for dashboards and reporting (ex: Tableau, QuickSight)
- Bonus: Experience with CMC manufacturing processes and data
- Excellent oral and written communication skills
- Ability to work independently and collaboratively among cross-functional teams, with a particular understanding for and drive to solve data issues faced by clinical scientists.
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.