Senior Lead Clinical Data Science Programmer

Senior Lead Clinical Data Science Programmer

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking an experienced Senior Lead Clinical Data Science Programmer to join our team. This role will be managed and covered via ICON Strategy Solutions.

What You Will Do:

Key responsibilities include:

• Lead DTS Development: Author and manage Data Transfer Specifications (DTS) to align external data providers and research partners on required data structures, formats, and templates.
• Oversee Data Standardization: Ensure study teams adhere to CDISC standards for external data, including biomarkers, wearable devices, IRT, imaging, and eCOA.
• Cross-Functional Collaboration: Serve as the primary contact for external data quality control, participating as an extended member of the Clinical Study Team and facilitating new test codes.
• Vendor & Process Management: Provide operational oversight to external data vendors, manage change requests for existing DTS, and contribute to continuous process improvement initiatives.
• Data Reconciliation & Compliance: Support data reconciliation, resolve structure inquiries, and comply with all regulatory requirements, including clinical protocols and analysis expectations.

Your Profile:

Required qualifications and experience:

• Professional Experience: Minimum of 8 years of external clinical data management or programming experience within the biotechnology, pharmaceutical, or health-related industry.
• Educational Background: Bachelor’s degree in Biology, Computer Science, Programming, Data Management, or a related scientific/analytic discipline.
• Technical Expertise: Advanced knowledge of extracting data into SAS, CSV, and XML formats, along with a strong understanding of database structures.
• Regulatory Knowledge: Deep understanding of data management processes, industry best practices, and applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards.
• Data Handling Skills: Proven experience managing multiple clinical data types (eCOA, imaging, and external data), with preferred expertise in biomarker and imaging data for oncology and non-oncology studies. Data Transfer Spec/Data Transfer Agreement experience required.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply