Senior Lead Clinical Data Science Programmer

🔥 10 minutes ago

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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.

🎯 Requirements

• Minimum of 8 years of external clinical data management or programming experience within the biotechnology, pharmaceutical, or health-related industry • Bachelor’s degree in Biology, Computer Science, Programming, Data Management, or a related scientific/analytic discipline • Advanced knowledge of extracting data into SAS, CSV, and XML formats • Strong understanding of database structures • Deep understanding of data management processes, industry best practices, and applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards • 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.

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways