Senior Lead Clinical Data Science Programmer

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Lead DTS Development: Create and oversee Data Transfer Specifications (DTS) to ensure alignment among external data providers and research partners regarding necessary data structures, formats, and templates.

• Oversee Data Standardization: Guarantee that study teams comply with CDISC standards for external data, which includes biomarkers, wearable devices, IRT, imaging, and eCOA.

• Cross-Functional Collaboration: Act as the main point of contact for external data quality control, engaging as an extended member of the Clinical Study Team and facilitating the introduction of new test codes.

• Vendor & Process Management: Deliver operational oversight for external data vendors, handle change requests for existing DTS, and contribute to initiatives aimed at continuous process improvement.

• Data Reconciliation & Compliance: Assist with data reconciliation, address structural inquiries, and ensure compliance with all regulatory requirements, including clinical protocols and analysis expectations.

⛳️ Requirements

• A minimum of 8 years of experience in external clinical data management or programming within the biotechnology, pharmaceutical, or health-related sectors.

• Bachelor’s degree in Biology, Computer Science, Programming, Data Management, or a related scientific/analytic field.

• Advanced expertise in extracting data into SAS, CSV, and XML formats.

• Strong comprehension of database structures.

• In-depth knowledge of data management processes, industry best practices, and relevant regulations, including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards.

• Demonstrated experience managing various clinical data types (eCOA, imaging, and external data), with preferred specialization in biomarker and imaging data for both oncology and non-oncology studies.

🏝️ Benefits

• Competitive base salary and performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.