Job Title: Senior Clinical Data Science Programmer
Company: ICON plc – Strategic Solutions Biometrics Portfolio
Location: Bangalore/Chennai (Hybrid Model)
Job ID: 2025-119047
About the Role:
ICON is hiring a Senior Clinical Data Science Programmer to streamline clinical data standards and improve efficiency in data collection and delivery. This dual-focused role centers around data collection standards (e.g., CRFs, DTAs, Rave eDC) and data delivery standards (e.g., SDTM, define.xml, metadata mapping) to ensure regulatory compliance, data integrity, and operational excellence across global clinical trials.
Key Focus Areas:
1. Standards Development & Configuration:
Design and manage clinical data standards for collection and delivery systems.
Customize standards for specific diseases or therapeutic areas.
Ensure detailed metadata lineage and traceability from master to study-specific implementations.
2. Data Collection Focus (If Applicable):
Implement standards in Medidata Rave eDC, including:
CRF mockups and validation rule specs.
Standard COAs and questionnaire forms.
Standard integrations (e.g., IWRS).
3. Data Delivery Focus (If Applicable):
Annotate CRFs with SDTM-compliant metadata to support submissions.
Develop standards for:
SDTM and define.xml documentation.
Data Transfer Agreements (DTA).
Metadata mapping from CRF/DTA to SDTM.
Collaboration & Support:
Act as a standards advisor to clinical data teams and CROs.
Promote consistent implementation of global standards across studies.
Work with a wide network of internal stakeholders including:
Standards leads, Data Managers, Technical Data Architects.
Clinical statisticians, physicians, CDISC working groups.
Required Skills & Experience:
For Data Collection Focus:
Strong experience with Medidata Rave eDC.
SAS programming knowledge preferred.
For Data Delivery Focus:
Strong experience in SAS programming for clinical data standards.
Exposure to Rave eDC is a plus.
Common Requirements:
Solid understanding of CDISC standards (SDTM, CDASH, Controlled Terminology, define.xml).
Familiarity with SAS LSAF and Pinnacle 21 preferred.
Bachelor’s degree in Life Sciences, Computer Science, or related field.
Minimum 2 years’ experience in clinical data management or standards.
Strong organizational, communication, and multitasking skills.
What ICON Offers:
Competitive compensation package.
Comprehensive health insurance options.
Retirement planning benefits.
Annual leave and wellness programs.
Access to TELUS Health for 24/7 global mental health support.
Country-specific perks like childcare vouchers, gym discounts, travel subsidies, etc.
Diversity & Accessibility Commitment:
ICON is an equal opportunity employer that values inclusion and belonging. Reasonable accommodations are available for candidates with disabilities. Visit ICON's Accessibility Page for more information.
If you’re interested in the role—even if you don’t meet every single requirement—ICON encourages you to apply. You might be just what they’re looking for.
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