Key skills
PythonVaultC#CRCommunicationRemote Work
About this role
Role Overview
- Support cross-functional teams such as Statistics, Data Management and Standards by overseeing clinical data build and programming activities.
- Review, validate datasets, specifications, and vendor artifacts.
- Collaborate with clinical study teams to define, implement, and enhance data quality methods.
- Maintain data quality control frameworks, ensuring alignment with CSL standards and regulatory expectations.
- Partner with Data Management, Statistics, and vendors to validate clinical data deliverables.
- Lead the development of data visualization and reporting solutions.
- Serve as a subject matter expert in CDASH, SDTM mapping, and EDC systems.
Requirements
- BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
- 5+ years of relevant experience (clinical data management, clinical programming, or a related function within a pharmaceutical or CRO environment)
- Strong understanding of clinical data processes
- Proficiency in SAS and familiarity with Python, R, or C# is a plus
- Solid knowledge of CDISC standards, including CDASH, SDTM, and ADaM
- Familiarity with EDC systems (e.g., Medidata Rave, Veeva Vault)
- Good communication and analytical skills
- Fluent in English, oral and in writing.
Tech Stack
- Python
- Vault
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options