Teams at Premier Research

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%.

Leads country-level clinical trial site start-up activities, including regulatory, ethics committee, and IRB submissions; forecasts approval timelines; resolves submission issues; manages essential document compliance; and supports investigator contract and budget negotiations. The role requires experience across clinical trial types, knowledge of FDA, EU, local regulations, ISO 14155, and ICH/GCP guidelines, plus leadership of larger start-up programs.