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Senior Lead Clinical Data Science Programmer

ICON PLC
4+ years
Not Disclosed
Bangalore, Chennai, Trivandrum, India
1 June 9, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Senior Lead Clinical Data Science Programmer

Locations: Bangalore, India | Chennai, India | Trivandrum, India
Work Model: Office or Home (Hybrid/Remote)
Job Type: Full-Time
Job Requisition ID: JR152724


About ICON

ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development and delivery of innovative medicines and therapies to patients worldwide.

Guided by our values of Integrity, Collaboration, Agility, and Inclusion, we empower our teams to drive scientific innovation, operational excellence, and meaningful healthcare impact.


Position Overview

We are seeking an experienced Senior Lead Clinical Data Science Programmer to lead external data integration, data transfer specification development, and clinical data science initiatives across global clinical trials.

This role is responsible for managing Data Transfer Specifications (DTS), ensuring compliance with CDISC standards, overseeing external data management processes, and collaborating with cross-functional stakeholders to support high-quality clinical data delivery and downstream analytics.

The ideal candidate will have deep expertise in clinical data management, biomarker and imaging data, external vendor data integration, CDISC standards, and clinical data programming.


Key Responsibilities

Data Transfer Specification (DTS) Leadership

  • Lead the development, review, and maintenance of Data Transfer Specifications (DTS) for external data providers.

  • Define and document data structures, transfer requirements, and integration standards.

  • Ensure consistency across multiple data vendors and study programs.

  • Manage DTS lifecycle activities, including updates, revisions, and change requests.

External Data Management

  • Serve as the primary point of contact for external data providers and research partners.

  • Coordinate external data acquisition and integration activities.

  • Monitor data transfer timelines and ensure study deliverables are achieved.

  • Resolve data structure and reconciliation issues in collaboration with vendors and study teams.

Clinical Data Integration

  • Oversee integration of various external clinical data sources, including:

    • Biomarker Data

    • Imaging Data

    • eCOA (Electronic Clinical Outcome Assessments)

    • Laboratory Data

    • Centralized Vendor Data

    • Clinical Endpoint Data

  • Ensure data consistency, quality, and regulatory compliance throughout the study lifecycle.

CDISC Standards & Data Governance

  • Ensure adherence to:

    • CDISC Standards

    • Data Collection Standards

    • Industry Best Practices

    • Internal Data Governance Requirements

  • Support study teams in implementing standardized external data collection methodologies.

  • Promote data harmonization across studies and therapeutic programs.

Clinical Study Team Collaboration

  • Participate as an extended member of Clinical Study Teams.

  • Collaborate with:

    • Clinical Data Management

    • Biostatistics

    • Clinical Operations

    • Medical Writing

    • Biomarker Teams

    • Imaging Vendors

    • Regulatory Teams

  • Provide technical expertise on external data requirements and data integration strategies.

Data Quality & Reconciliation

  • Support external data reconciliation activities.

  • Investigate and resolve data discrepancies.

  • Ensure external data aligns with protocol requirements and study objectives.

  • Maintain data integrity throughout the clinical trial lifecycle.

Programming & Data Extraction

  • Support extraction and processing of clinical data in various formats, including:

    • SAS

    • CSV

    • XML

  • Review and validate data structures to support reporting and analytics requirements.

  • Ensure downstream systems receive standardized and high-quality datasets.

eCRF & EDC Support

  • Review and contribute to:

    • Electronic Case Report Forms (eCRFs)

    • Electronic Data Capture (EDC) Configurations

    • External Data Collection Workflows

  • Ensure EDC systems support external data requirements effectively.

Vendor Oversight & Relationship Management

  • Provide oversight of external data vendors and service providers.

  • Facilitate functional discussions and issue resolution.

  • Establish strong vendor partnerships and communication channels.

  • Escalate risks and operational issues when required.

Training & Mentorship

  • Train and mentor team members on:

    • DTS Development

    • External Data Standards

    • Data Integration Processes

    • Industry Best Practices

  • Support knowledge-sharing initiatives and continuous professional development.

Process Improvement

  • Drive continuous improvement initiatives related to external data management.

  • Enhance DTS templates and data integration workflows.

  • Improve data standardization and operational efficiency.

  • Support innovation in clinical data science processes.


Required Qualifications

Education

Bachelor’s or Master’s Degree in:

  • Life Sciences

  • Computer Science

  • Biotechnology

  • Biostatistics

  • Data Science

  • Pharmacy

  • Healthcare Informatics

  • Related Scientific or Technical Discipline