Principal Statistician (Pharmacokinetics)

Experteer Overview In this role you will lead statistical activities for global clinical trials, collaborating with international teams of statisticians, programmers and data managers. You will design and review analyses, SP/ADA procedures, and QA statistical deliverables while guiding junior team members. You’ll engage in audits, SOP/QSD contributions, and cross-functional communication to support high-quality clinical research. This position offers impact in shaping analysis strategies for trials and profiles your leadership in a dynamic CRO environment. Retribuzione / Benefits

Act as primary communication liaison for project teams, clients, vendors, and internal statisticians on statistical questions Perform statistical analyses for clinical trials, including interim, final, DSMB/DMC, and PK analyses Develop and review protocols, SAPs, and analysis datasets per CDISC ADaM and project documents Review statistical deliverables such as tables, figures, listings, and analysis datasets Lead departmental induction and project-specific training for statisticians and SAS programmers Prepare for and participate in internal and external study audits; follow-up on audits Contribute to SOPs and Quality System Documents for Biostatistics activities Liaise with Data Management on statistical data issues Participate in bid defenses and project kick-off meetings Lead teams of SAS programmers and statisticians at the project level Responsabilità

MSc in Statistics or equivalent Full working proficiency in English Expert knowledge of statistical principles, methods, and standards in clinical research Expert knowledge of SAS programming Expert knowledge of CDISC ADaM standard Expert knowledge of pharmacokinetics in clinical research, including NCL and population PK analysis Expert knowledge of Phoenix WinNonlin and NLME Expert knowledge of relevant regulations (FDA, EMA, ICH) Ability to apply advanced statistical techniques to support clinical studies and interpret complex results Ability to consult with clinical investigators and determine analysis strategies Strong presentation and communication skills

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