Clinical Data Configuration Engineer (FSP) – SDTM Programming / Mapping
Company: ICON plc
Location: Bangalore / Livingston
Work Mode: Office or Home (Hybrid / Remote)
Employment Type: Full-time
Experience Required: 5+ Years
Salary: ₹18 LPA – ₹28 LPA (Estimated for SDTM/Data Standards roles in India)
Job Overview
ICON plc is looking for a Clinical Data Configuration Engineer (FSP) with strong expertise in SDTM programming and CDISC standards.
In this role, you will design and implement advanced clinical data systems that support efficient clinical trial execution while ensuring compliance with regulatory standards. You will collaborate with cross-functional teams to enhance clinical data workflows and maintain high-quality SDTM data standards implementation.
Key Responsibilities
Lead the design and development of clinical data systems aligned with study protocols and operational requirements.
Create and review SDTM specifications and ensure ownership of data standards implementation.
Define SDTM mapping rules, variable derivations, and data transformation logic.
Collaborate with clinical operations, data management, and programming teams to improve system performance.
Configure, integrate, and test clinical systems and data pipelines.
Ensure quality control (QC) and adherence to SDTM/CDISC standards across the team.
Provide strategic input on new technologies and best practices in clinical data systems.
Support continuous improvement by staying updated with industry standards and clinical technology trends.
Required Qualifications
Master’s degree in Computer Science or a related field.
5+ years of experience in clinical data systems, SDTM programming, or data standards roles.
Strong knowledge of CDISC and SDTM standards.
Experience with SDTM specification creation, review, and ownership.
Strong understanding of SDTM mapping rules and variable derivations.
Experience ensuring team adherence to SDTM standards through QC processes.
Familiarity with SAS and R programming for implementing specifications.
Understanding of end-to-end clinical data flow from raw data to SDTM datasets.
Preferred Experience
Experience working in data standards teams with SDTM focus.
Ability to interpret study-specific and global data standards.
Experience contributing to SDTM or data standards development.
Benefits
Employees at ICON plc may receive benefits such as:
Competitive salary and performance incentives
Paid annual leave and holidays
Comprehensive health insurance for employees and families
Retirement and savings plans
Global Employee Assistance Programme (TELUS Health) for wellbeing support
Life insurance coverage
Flexible benefits including childcare support, gym memberships, travel subsidies, and wellness programsa
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