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Senior Clinical Data Science Programmer

6+ years
Not Disclosed
10 Nov. 10, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: Senior Clinical Data Science Programmer
Company: ICON Strategic Solutions
Location: India (Remote)
Portfolio: Biometrics
Job ID: 2025-121459
Hiring Manager: Kalpana Kulasekaran


About the Role:

As a Senior Clinical Data Science Programmer, you will join the world’s largest and most comprehensive clinical research organization, leveraging healthcare intelligence to design, manage, and validate clinical trials.


Key Responsibilities:

EDC & Clinical Trial Setup:

  • Design, develop, and validate clinical trials in EDC systems.

  • Manage edit check specifications and configure trial-level edit checks.

  • Execute UAT scripts to test study or EDC platform setup.

  • Configure study instances (e.g., UAT, production, testing).

  • Facilitate user access requests for study teams.

  • Set up and manage blinded and unblinded study configurations.

  • Serve as SME for all EDC database activities at the trial level.

  • Integrate EDC with other clinical trial modules (lab, safety, IRT, coding).

  • Troubleshoot database setups as per study requirements.

  • Perform impact assessments and implement post-production changes.

Collaboration & Vendor Management:

  • Drive adoption of new capabilities and business processes.

  • Serve as the contact for Clinical Technology vendors to ensure milestone delivery.

  • Work with leadership, technology vendors, and CRO partners to resolve risks.

  • Lead technology vendor oversight and ensure trial readiness for audits and inspections.

Documentation & Compliance:

  • Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents.

  • Participate in preparation for regulatory submissions and represent the Clinical Trial Configuration group during formal inspections.


Required Education & Skills:

  • Bachelor’s degree.

  • Knowledge of drug development processes.

  • Minimum 6 years of experience in Data Management, Clinical Programming, or related Clinical Research fields, including at least 4 years in EDC programming.

  • Hands-on experience with Veeva (mandatory); experience with Medidata Rave, Oracle Inform, etc., is a plus.

  • Programming experience in CQL, CDB, JSON, or C# preferred but not required.

  • Experience integrating EDC with other clinical trial modules (lab, safety, IRT, coding, etc.).

  • Familiarity with industry-standard technologies to support Clinical Development (e.g., CTMS, SAS, R, Python, Data Warehouses, SharePoint).


Benefits & Culture:

  • Competitive salary with diverse benefits focused on well-being and work-life balance.

  • Annual leave entitlements, health insurance, retirement planning, life assurance, and employee assistance programs.

  • Flexible, country-specific optional benefits (childcare vouchers, gym discounts, travel subsidies, etc.).

  • Inclusive and accessible work environment; commitment to equal opportunity employment.

More info on benefits: ICON Careers Benefits
Reasonable accommodations: ICON Reasonable Accommodations


Inclusion Statement:

ICON is committed to inclusion, belonging, and a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.