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Principal Clinical Data Standards Consultant

2+ years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Remote Education: Bachelor's degree in Life Sciences, Computer Science, or a related discipline. 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

Job Title: Principal Clinical Data Standards Consultant

Job ID: JR128681
Location: Bangalore, Chennai, Bengaluru (Office-based or Remote)
Department: ICON Full Service & Corporate Support – Data Standards
Reporting Manager: Sunidhi Sinha
🔗 Apply Now via ICON Careers


About ICON plc

ICON plc is a global leader in healthcare intelligence and clinical research. Our inclusive culture is built on driving innovation and excellence. We invite you to join us on our mission to shape the future of clinical development.


Position Summary

We are seeking a Principal Clinical Data Standards Consultant with deep expertise in SDTM standards and proficiency in R and SAS programming. In this strategic role, you will develop, implement, and maintain SDTM standards and tools for internal use and for our sponsors.


Key Responsibilities

  • Develop and implement ICON’s SDTM standards libraries and mapping strategies.

  • Create tools and macros to facilitate SDTM standards implementation.

  • Provide consulting services internally and externally on SDTM compliance, best practices, and implementation strategies.

  • Assist sponsors in creating, maintaining, and governing clinical data standards content.

  • Support and enhance technologies and systems used for SDTM implementation and automation.

  • Actively participate in standards governance meetings and provide input on regulatory and industry requirements.

  • Collaborate across departments and sponsor teams to drive data standardization excellence.


Required Qualifications

Education

  • Bachelor's degree in Life Sciences, Computer Science, or a related discipline.

Experience

  • 10–15 years of experience in clinical data standards, clinical programming, or related fields within pharma/CRO/biotech.

  • Proven expertise with SDTM, SDTM Implementation Guides, and Controlled Terminology.

  • Strong programming experience in R and SAS (knowledge of other programming languages is a plus).

Skills

  • Ability to provide strategic input and technical guidance across projects.

  • Leadership experience with the ability to mentor junior staff and lead initiatives.

  • Problem-solving acumen with a strong understanding of clinical trial operations.

  • Strong communication and collaboration skills across technical and non-technical teams.

  • Ability to present complex analysis and influence stakeholders effectively.

  • Willingness to travel occasionally (less than 5%).


What ICON Offers You

Our commitment to you goes beyond compensation. ICON supports your career development, well-being, and work-life balance.

Key Benefits:

  • Generous annual leave entitlements

  • Comprehensive health insurance plans for you and your family

  • Retirement planning programs to help you secure your future

  • Access to LifeWorks Global Employee Assistance Programme (EAP) for 24/7 support

  • Life assurance

  • Country-specific flexible benefits, such as:

    • Childcare vouchers

    • Bike purchase schemes

    • Discounted gym memberships

    • Subsidized travel passes

    • Health assessments

🔗 Explore ICON’s Global Benefits


Diversity & Inclusion

ICON is committed to creating a diverse, equitable, and inclusive workplace. We provide equal opportunity in employment without discrimination based on race, gender, disability, veteran status, or other protected characteristics.

If you need a reasonable accommodation to complete the application or perform job responsibilities:
🔗 Submit a Request Here


Not Sure You Meet All the Requirements?

We encourage you to apply anyway — you may be exactly who we’re looking for, whether for this or other exciting roles at ICON.


Quick Links

📍 Locations: Bangalore | Chennai | Bengaluru
🏠 Work Setup: Office-based or Remote
👩‍💼 Hiring Manager: Sunidhi Sinha
🔗 ICON Careers Portal