Senior Clinical Data Science Lead

Senior Clinical Data Science Lead

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.

As a Senior Clinical Data Science Lead at ICON, you will lead the analysis, interpretation, and management of clinical data to drive the success of our clinical trials.

Key Responsibilities

• Lead clinical data science activities across global clinical trials, ensuring high-quality, timely, and regulatory-compliant data delivery
• Act as the primary data lead within cross-functional study teams, partnering with sponsors and internal stakeholders
• Ensuring alignment with agreed timelines, scope, and quality expectations
• Drive study start-up activities including EDC build, system integrations (ePRO, IRT, eCOA), and user acceptance testing (UAT)
• Lead the development and execution of key data documentation such as Data Management Plans, Data Review Plans, and Edit Check Specifications
• Oversee data cleaning, query management, and cross-functional data review processes
• Manage external data reconciliation and vendor data integration activities
• Lead database lock activities (interim and final), ensuring inspection readiness and data integrity
• Identify and mitigate risks, proactively resolving complex data-related issues and escalations
• Ensure compliance with CDISC standards, ICH-GCP, and regulatory requirements
• Contribute to budget management, KPI tracking, and continuous improvement initiatives
• Drive innovation through adoption of new technologies and data science approaches

Your Profile: Required Qualifications and Experience

• Education: Bachelor’s degree in Life Sciences, Health Sciences, or a related scientific/technical discipline.
• Industry Experience: 6–10+ years of progressive experience in clinical data management or clinical data science within a CRO or pharmaceutical environment.
• Study Leadership:
  Proven track record leading data management activities across the full clinical trial lifecycle (start-up, conduct, and close-out).
  Minimum of 3 years serving as the primary lead on complex, in-house studies, or 5+ years of hands-on experience driving data review and reconciliation (including EDC, external vendors, eCOA, IRT, and SAEs).
• Vendor & Oversight Management: Strong experience in vendor oversight and managing outsourced data delivery models.
• Technical Expertise:
  Hands-on experience with Electronic Data Capture systems (Veeva EDC preferred) and external data integrations.
  Expert knowledge of clinical data standards, including CDISC (SDTM preferred).
• Regulatory & Compliance:
  In-depth understanding of clinical trial processes, regulatory frameworks (ICH-GCP, FDA), and data workflows.
  Experience supporting regulatory submissions (NDA/CTD) is highly advantageous.
• Core Competencies:
  Exceptional project management, organizational, and proactive problem-solving skills.
  Excellent communication and negotiation skills, with a demonstrated ability to influence stakeholders in a matrix environment.
  Ability to work independently, mitigate data risks, and thrive within fast-paced, global teams.

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