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Stats, stats programming, pk and medical writing - clinical programmer ii

Edinburgh
Medical writer
Posted: 10 April
Offer description

The Role We’re looking for a Clinical Programmer II to join our Clinical Programming team within the Data Sciences department. This is a hybrid role based at our Edinburgh site. In this role, you will prepare data transfer and dataset specifications, review Data Management Plans (DMPs), support eSource documentation, and undertake end‑to‑end programming and validation of SDTM datasets. You will also perform SAS consistency checks, data reconciliation, and non‑define dataset transfers. You will ensure all activities are completed to the highest quality standards and in accordance with clinical protocols, SOPs, CDISC guidelines, regulatory requirements, and established timelines. What You’ll Do Lead clinical programming activities for assigned studies, attending Data Sciences KOM and Pre‑Lock meetings to provide programming input and study updates. Review Data Management Plans (DMPs) and CRFs Prepare external data transfer specifications Prepare SDTM dataset specifications, programming and double‑programming SDTM datasets, and carrying out validation for safety data; provide programming and validation support for non‑safety SDTM datasets, Receive, load, and reconcile external data, carrying out both routine and non‑routine SAS consistency checks. Complete post‑lock data activities, including extracts, unblinding receipt, randomisation merge file programming, and non‑define SDTM data transfers. Maintain accurate, organised, and audit‑ready study documentation in line with Quotient processes. Deliver programming activities within agreed timelines while keeping line management informed of study progress, risks, and issues. Monitor study scope and escalate out‑of‑scope sponsor requests to senior management. Ensure all work adheres to departmental SOPs, safety procedures, and regulatory requirements. Work collaboratively across teams, supporting business needs by undertaking additional tasks where required and contributing flexibly to department operations. Participate in overtime when necessary to support the smooth running of the department. About You • Degree in a scientific or numerate discipline• Experience in clinical programming or a related field• Strong SAS programming skills, including complex programming• Excellent communication, attention to detail and problem‑solving skills• Proficient with Word, Excel and Email• Knowledge of clinical data, ICH/GCP and CDISC• Able to prioritise, work independently, and thrive in a fast‑paced environment The closing date for applications is 22nd April 2026.

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