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Principal Clinical Data Standards Consultant

10-15 years
Not Disclosed
10 Nov. 12, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Principal Clinical Data Standards Consultant

Locations: Bangalore, Chennai, Bengaluru
Job ID: JR128681
Department: ICON Full Service & Corporate Support – Data Standards Consultant
Work Model: Office or Home (Remote Option Available)


About the Role

ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to innovation, excellence, and diversity. As a Principal Clinical Data Standards Consultant, you will play a strategic role in shaping and implementing CDISC SDTM standards to support both internal initiatives and global sponsor projects.

You will provide technical leadership, consultation, and governance for data standardization, SDTM implementation, and programming automation, ensuring compliance and consistency across clinical data processes.


Key Responsibilities

  • Develop and implement ICON’s internal SDTM standards libraries, including tools and macros for seamless data mapping.

  • Provide consulting services on SDTM compliance, data mapping, and implementation for both internal teams and external sponsors.

  • Support sponsors in developing, maintaining, and governing their clinical data standards content.

  • Contribute to the design and maintenance of technologies and systems that support SDTM standards implementation.

  • Participate in standards governance committees and offer expert input on data standardization strategies.

  • Lead departmental initiatives, mentor junior programmers and standards specialists.

  • Collaborate with internal stakeholders to ensure alignment with industry best practices and regulatory expectations.

  • Apply business and technical expertise to recommend improvements and optimize standardization processes.

  • Occasionally travel (<5%) to attend project meetings or governance discussions as required.


Required Qualifications & Experience

  • Education: Bachelor’s or Master’s degree in Life Sciences, Computer Science, Data Science, or related field.

  • Experience: 10–15 years of relevant experience in clinical data standards, SDTM programming, and data management.

  • Technical Skills:

    • Expert-level knowledge of SDTM standards, SDTM Implementation Guides, and Controlled Terminology.

    • Proficiency in SAS and R programming languages (other languages an advantage).

    • Experience with data standardization tools, automation macros, and standards governance frameworks.

  • Strong analytical and problem-solving skills with proven ability to impact operational objectives.

  • Excellent leadership, mentoring, and cross-functional collaboration capabilities.

  • Exceptional communication and stakeholder engagement skills.


Experience Level

  • Senior to Principal Level

  • Typically 10–15 years of experience in clinical data standards, programming, and governance roles.


Job Category

  • Primary Category: Clinical Data Standards / Clinical Programming

  • Subcategories:

    • CDISC Standards Development (SDTM, ADaM)

    • Data Governance and Compliance

    • Programming and Automation

    • Data Standardization Consulting


What ICON Can Offer You

ICON is committed to building a culture that rewards performance and nurtures growth. We offer competitive compensation and benefits tailored to support your well-being and career development.

Examples of Benefits:

  • Comprehensive annual leave entitlements

  • Diverse health insurance plans for you and your family

  • Competitive retirement savings and financial planning options

  • Global Employee Assistance Programme (LifeWorks) with 24/7 support access

  • Life assurance coverage

  • Country-specific optional benefits such as:

    • Childcare vouchers

    • Bike purchase schemes

    • Discounted gym memberships

    • Subsidized travel passes

    • Health assessments