Principal Statistician (Pharmacokinetics)

PSI Software

Consultoría de TI

Madrid - Spanien

Manager / Gestor de equipos

Experteer Overview

As Biostatistics Project Lead, you drive statistical strategy and analysis for global clinical trials. You will collaborate with international statisticians, programmers, and data managers to ensure high-quality deliverables and regulatory compliance. You lead SAS programming teams, influence study design and analysis plans, and support audits and quality systems. This role offers impact on trial outcomes and opportunities to shape statistical methods in a global setting. Join a mission-driven CRO focused on bringing new medicines to patients.

Responsabilidades

Act as the primary statistical point of contact for project teams, clients, vendors and internal staff
Conduct statistical analyses for trials including interim, final, DSMB/DMC, and PK analyses
Develop and review protocols, SAPs, and ADaM datasets
Review deliverables (tables, figures, listings, datasets) for quality and accuracy
Provide training for statisticians and SAS programmers
Prepare for and participate in audits related to Statistics and follow-up actions
Contribute to SOPs and Quality System documents relevant to Biostatistics
Coordinate with Data Management on statistical data issues
Lead SAS programmers and statisticians at project level
Participate in bid defense and project kick-offs

Requisitos principales

MSc in Statistics or equivalent
Fluent English
Expert knowledge of statistical principles and methods used in clinical research
Expert SAS programming knowledge
Expert CDISC ADaM knowledge
Expert pharmacokinetics knowledge and PK analysis methods
Expert Phoenix WinNonlin and NLME knowledge
Expert regulatory knowledge (FDA, EMA, ICH)
Ability to apply advanced statistical techniques to clinical studies
Ability to consult with investigators and define analysis strategies
Strong presentation and communication skills