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Senior Lead Clinical Data Science Programmer

Remote · USA Full-time New today

Senior Lead Clinical Data Science Programmer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 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. Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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 Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply Apply To This Job

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