Build the Digital Foundation for Life-Saving Clinical Trials
ICON plc is a world-leading healthcare intelligence and clinical research organization. We give our clients the people, processes, and technologies they need to transform clinical data into the clear, compliant evidence that brings new medicines to patients faster.
We are seeking a Clinical Data Validation Engineer Specialist (Lead Clinical Data Science Programmer) to be our technical authority in data solutions. In this pivotal role, you will architect, build, and validate the robust programming frameworks that ensure the integrity of clinical trial data. You will lead the technical charge to transform raw data into reliable insights that meet stringent CDISC and regulatory standards, directly impacting drug development decisions.
YOUR MISSION: THE ARCHITECT OF DATA INTEGRITY ⚙️
You will be the engineering lead responsible for designing and validating the critical data pipelines and programming outputs that underpin clinical trial analysis. Your expertise ensures that every dataset, table, listing, and figure (TLF) is accurate, reproducible, and submission-ready.
MAIN RESPONSIBILITIES & ACCOUNTABILITIES 📊
- Technical Leadership & Architecture: Lead the design, development, and validation of complex data science programming solutions for clinical trials, setting the technical standard for the team.
- CDISC Standards Mastery: Program and validate SDTM and ADaM datasets and all corresponding TLFs (Tables, Listings, Figures) to the highest quality, ensuring flawless regulatory submission readiness.
- Cross-Functional Collaboration: Partner closely with Biostatisticians, Data Managers, and Clinical Scientists to develop precise data specifications, analysis plans, and validation strategies.
- Quality Engineering: Implement and oversee rigorous quality control and validation checks to guarantee the accuracy, consistency, and integrity of all clinical data outputs.
- Mentorship & Knowledge Sharing: Provide expert technical guidance and mentorship to junior programmers, fostering a culture of excellence and continuous improvement within the data science programming team.
YOUR PROFILE: QUALIFICATIONS & EXPERIENCE 👤
ESSENTIAL REQUIREMENTS:
- Bachelor’s or advanced degree in Computer Science, Biostatistics, Data Science, Life Sciences, or a directly related field.
- Extensive experience in clinical data programming, with expert-level proficiency in SAS (primary) and/or R.
- In-depth, hands-on knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical data submissions (e.g., FDA, EMA).
- Proven track record of leading the programming and validation of datasets and TLFs for multiple clinical trials from start to completion.
- Strong analytical and problem-solving skills with an uncompromising focus on data accuracy, quality, and reproducibility.
- Excellent communication and leadership skills, with the ability to manage multiple projects, collaborate across global teams, and translate technical requirements clearly.
HIGHLY DESIRED SKILLS:
- Experience with other programming languages (Python, SQL) and data visualization tools.
- Direct experience with electronic submission processes (e.g., eCTD).
- Prior role in a lead or specialist capacity, mentoring other programmers.
WHY JOIN ICON'S DATA SCIENCE TEAM? 💡
- Technical Impact: Your work is the critical engineering layer that turns clinical data into trusted evidence, directly influencing key development milestones.
- Expert-Level Role: Operate as a subject matter expert and technical lead with significant autonomy and influence over data solutions.
- Career Advancement: Grow your career as a specialist or people leader within a global organization dedicated to technical excellence in clinical data.
- Cutting-Edge Environment: Work with the latest technologies and methodologies in clinical data programming and analytics.
- Comprehensive Well-being: Receive a competitive salary and a full benefits package focused on health, finance, and work-life balance, including our global employee assistance program.
READY TO ENGINEER THE DATA SOLUTIONS THAT POWER MEDICAL BREAKTHROUGHS? 🚀
APPLY NOW FOR THE CLINICAL DATA VALIDATION ENGINEER SPECIALIST POSITION.
ICON is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We encourage all qualified applicants to apply. If you require reasonable accommodations during the application process, please let us know.