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Clinical Data Configuration Engineer Fsp - Sdtm Programming/Mapping

Icon Plc
ICON PLC
5+ years
Not Disclosed
Bangalore, Livingston, United States
10 March 11, 2026
Job Description
Job Type: Hybrid Remote Education: MCS/M.E./M.Sc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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