Experteer Overview
In this Biostatistics Project Lead role, you drive statistical activities for global clinical trials and coordinate with cross-functional teams of statisticians, programmers, and data managers. You design analysis plans, review deliverables, and lead SAS-driven analyses including interim, final, DSMB/DMC, and PK analyses. You will train staff, support audits, and contribute to quality systems and study documentation. This role combines leadership with technical excellence to advance clinical research outcomes within a global, mission-driven CRO.
Retribuzione / Benefits
* Act as primary statistical liaison for project teams, clients, vendors and internal colleagues
* Conduct complex statistical analyses for clinical trials (interim, final, DSMB/DMC, PK)
* Develop and review protocols, SAPs, and SDS aligned with CDISC ADaM and project docs
* Review statistical deliverables (tables, figures, listings, datasets) for quality and accuracy
* Lead and mentor SAS programmers and statisticians on projects
* Participate in audits and audit follow-up activities
* Contribute to SOPs and Quality System documents relevant to Biostatistics
* Collaborate with data management on data issues and data-driven decision making
* Lead bid defense and project kick-off meetings
* Liaise with cross-functional teams to ensure statistical questions are resolved efficiently
Responsabilità
* MSc in Statistics or equivalent
* Full working proficiency in English
* Expert knowledge of statistical principles and methods used in clinical research
* Expert knowledge of SAS programming
* Expert knowledge of CDISC ADaM
* Expert knowledge of pharmacokinetics concepts and PK analysis
* Expert knowledge of Phoenix WinNonlin and NLME
* Expert knowledge of relevant FDA/EMA/ICH regulations and guidelines
* Ability to apply advanced statistical techniques and interpret complex analysesStrong presentation and communication skills
* Experience leading teams of SAS programmers and statisticians
* Ability to consult with investigators and define analysis strategies
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