Jobs at Premier Research

Leads study start-up performance and teams across the United Kingdom, managing staffing, resources, utilization, timelines, process efficiency, contractual compliance, and risk management. Collaborates with global SSU leadership to standardize processes and improve team capabilities. Requires clinical or scientific expertise, substantial clinical trials or pharmaceutical industry experience, personnel management experience, and detailed knowledge of ICH/GCP, ISO 14155, FDA, European, and country-specific regulatory requirements.

Develops, validates, and supports R Shiny applications and reusable programming utilities for clinical trial review, data visualization, statistical reporting, quality control, and regulatory submissions. Uses R, SAS, and Python while collaborating with biostatisticians, statistical programmers, data management, clinical operations, and IT. Ensures solutions meet GxP, Computer Software Assurance, testing, scalability, performance, and company standards.

Supports clinical data science and management activities for clinical trials, including database development, eCRF and edit-check planning, user acceptance testing, external data coordination, risk assessment, documentation, study metrics, budget oversight, and compliance with SOPs. The role also coordinates data team activities, manages timelines, and communicates with internal teams and external vendors.

Design, develop, test, and maintain scalable R Shiny applications for clinical data review, visualization, QC, and reporting. Build reusable modules and utilities (R, SAS, Python), integrate cloud data sources, validate to regulatory/GxP standards, optimize performance, perform testing, and support study teams.

Lead statistician for complex clinical studies from protocol/SAP planning through reporting; develop sample size, modeling, adaptive/Bayesian designs; oversee statistical deliverables (SAPs, randomization, CSR contributions), advise on regulatory strategy, manage biostatistics projects and budgets, support BD and DSMB/DMC activities. Travel ~20%.