As a Senior Clinical Data Science Programmer at ICON, you will be responsible for implementing and maintaining efficient standard content in data collection and delivery tools. You will support metadata standards that facilitate the seamless data flow from collection to delivery in alignment with industry standards and regulatory requirements. This role will work in close collaboration with clinical data collection and analysis teams to ensure optimal adoption and reuse of standards across trials and therapeutic areas.
This position has two main focus areas:
Data Collection – Focusing on CRFs, DTAs, and Rave eDC standards
Data Delivery – Focusing on SDTM, controlled terminology, and metadata mapping
Standards Development & Configuration:
Design, implement, and manage clinical data standards across collection and delivery tools to enhance trial efficiency and data consistency.
Tailor standards to meet the scientific and operational needs of specific disease or therapeutic areas.
Ensure robust traceability from master standards through to study-specific implementations, maintaining detailed metadata lineage.
Data Collection Focus (if applicable):
Implement standard content in Medidata Rave eDC, including:
CRF mockups
Standard questionnaires and COAs
Validation rule specifications
Standard integrations (e.g., IWRS)
Data Delivery Focus (if applicable):
Annotate CRFs with SDTM-compliant metadata to support regulatory submissions and operational excellence.
Support content such as:
SDTM and define.xml creation
Annotated CRFs
Data Transfer Agreement standards
Metadata mapping (CRF/DTA to DRM, DRM to SDTM)
Collaboration & Support:
Act as a standards expert and advisor to clinical data management and clinical programming teams, as well as CRO partners.
Provide guidance on effective adoption and implementation of standards across global studies.
Key Interfaces:
Primary: Standards leads (data collection and delivery), Data Managers, Technical Data Architects
Secondary: Clinical teams (statisticians, physicians), Clinical Analysis Standards, CDISC working groups
For Data Collection Focus:
Strong hands-on experience with Rave eDC (Medidata Solutions)
SAS programming knowledge preferred
For Data Delivery Focus:
Experience with SAS programming for clinical data standards
Exposure to Rave eDC is advantageous
Common Requirements:
Solid understanding of CDISC standards (SDTM, CDASH, Controlled Terminology, define.xml)
Experience with SAS LSAF and Pinnacle 21 is a plus
Bachelor’s degree in Life Sciences, Computer Science, or equivalent professional experience
Minimum of 2 years in clinical data management, standards, or related functions
Strong organizational skills and the ability to manage multiple priorities
Excellent written and verbal communication skills in English