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09.29.21
South San Francisco, California, United States
Senior Clinical Data Architect
Information Sciences
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Respect, Science, Courage and Collaboration and it reflects who we are and the environment we are creating.
 

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

PREFERRED EXPERIENCE:

  • 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)

PREFERRED EDUCATION:

  • 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.
 
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
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.
 
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
 
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.
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