Jobs 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.

Design, build, test, and maintain scalable R Shiny applications and reusable programming utilities (R/SAS/Python) for clinical data review, visualization, QC, and reporting. Ensure applications meet GxP/CSA and regulatory standards, optimize performance for many users, develop testing suites, and provide technical consultation and programming support to study teams.

Prepare and analyze contract payment schedules, monthly revenue, backlog, invoices, and cash flow for assigned CRO projects. Support project managers with profitability tracking, change order analysis, and financial reporting; attend project meetings and assist finance and project teams.

Design, develop, test, and maintain scalable R Shiny applications and reusable programming utilities (R, SAS, Python) for clinical data review, visualization, QC, and regulatory-compliant reporting. Optimize performance and scalability, integrate cloud data sources, validate applications to GxP/FDA/EMA standards, execute application testing, and support study teams with programming deliverables (ADaM, TLFs). Provide technical consultation and contribute to open-source R/Shiny projects.

Design, develop, test, and maintain scalable R Shiny applications and reusable programming utilities (R, SAS, Python) to support clinical data review, visualization, QC, and regulatory-compliant reporting. Optimize performance, validate per GxP/FDA/EMA, build testing suites, consult on R/Shiny solutions, and support study programming deliverables.

Prepare and review contract payment schedules, invoices, and monthly contract revenue for assigned clinical development projects. Analyze budgets, hours, change orders, backlog, and cash flow; support project managers on profitability tracking and attend project meetings. Provide ad-hoc financial analyses and assist finance and project teams as needed.

Design, develop, test, and maintain scalable R Shiny applications supporting clinical trial analysis, visualization, and reporting. Integrate Shiny apps with cloud storage, build reusable modules and programming utilities (R, SAS, Python), validate software to regulatory standards (GxP/FDA/EMA), execute testing, and provide technical consultation to support study teams and project deliverables (ADaM, TLFs, SDTM).

Design, develop, test, and maintain scalable R Shiny applications and reusable utilities for clinical data analysis (SDTM/ADaM). Optimize performance, validate to GxP/FDA/EMA standards, integrate cloud data sources, implement testing, and support study teams with programming and reporting deliverables.

Manage full trial budget lifecycle and proposal pricing for CRO services: cost analysis, budget development (OOP and FTE), change orders, stakeholder coordination, resource fee preparation, and proposal production. Interface with project and contract teams, provide pricing guidance, and support process improvements and lessons-learned.

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%.

Prepare monthly US GAAP management accounts, P&L and balance sheet reports, tax compliance, journals, reconciliations and variance analysis. Support multiple legal entities, provide transactional detail to local accountants, respond to financial inquiries, assist year-end and statutory accounts, and support/train finance staff and the Finance Manager.

The Sr/Site Start Up Associate II will manage regulatory applications, site identification, and contract negotiations, ensuring compliance with local regulations and guidelines for clinical trials.

Lead statistical strategies for complex client studies, ensuring effective communication and innovative statistical analysis in clinical trials.

Prepare and submit central and local EC/IRB, regulatory and hospital approvals; manage amendments and safety notifications; collect and QC essential documents; negotiate local investigator contracts and budgets; conduct country-level site feasibility; prepare IP checklists and ensure TMF completeness throughout study start-up.

As a Principal Biostatistical Programmer, you will develop SAS programs for clinical trials, perform quality control, generate analysis datasets, and lead interactions with study teams.

Conduct onsite and remote monitoring visits per ICH GCP/ISO14155 and protocol to ensure data integrity, patient safety, TMF maintenance, IP accountability, query resolution, site communication, and project support. Manage administrative duties, mentor CRAs, assess feasibility/recruitment, and meet travel and regulatory requirements.

Lead design, deployment, monitoring, and maintenance of server, VM, storage, and network infrastructure. Ensure regulatory compliance (e.g., 21 CFR Part 11), troubleshoot performance incidents, manage projects, update documentation, and recommend Data Center and infrastructure improvements.

Lead cross-functional global project teams for dermatology clinical programs, ensuring milestone delivery, budget and scope adherence, compliance with processes, client liaison and meeting leadership, support proposal/business development, and cultivate client relationships to drive future business.

As a Senior Project Manager, oversee project management tasks, budget adherence, client relations, and business development in the Neuroscience sector.

Coordinate and facilitate on-site clinical trial activities ensuring compliance with protocol, GCP, and local regulations. Support the Principal Investigator and site team with data entry, TMF maintenance, regulatory/ethics submissions, patient scheduling and enrollment, samples logistics, site monitoring visits, and site performance reporting. Build and maintain potential patient databases and support community/patient-awareness events.