Ph3Experteer Overview /h3pIn 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. /ph3Retribuzione / Benefits /h3ulliAct as primary statistical liaison for project teams, clients, vendors and internal colleagues /liliConduct complex statistical analyses for clinical trials (interim, final, DSMB/DMC, PK) /liliDevelop and review protocols, SAPs, and SDS aligned with CDISC ADaM and project docs /liliReview statistical deliverables (tables, figures, listings, datasets) for quality and accuracy /liliLead and mentor SAS programmers and statisticians on projects /liliParticipate in audits and audit follow-up activities /liliContribute to SOPs and Quality System documents relevant to Biostatistics /liliCollaborate with data management on data issues and data-driven decision making /liliLead bid defense and project kick-off meetings /liliLiaise with cross-functional teams to ensure statistical questions are resolved efficiently /li /ulh3Responsabilità /h3ulliMSc in Statistics or equivalent /liliFull working proficiency in English /liliExpert knowledge of statistical principles and methods used in clinical research /liliExpert knowledge of SAS programming /liliExpert knowledge of CDISC ADaM /liliExpert knowledge of pharmacokinetics concepts and PK analysis /liliExpert knowledge of Phoenix WinNonlin and NLME /liliExpert knowledge of relevant FDA/EMA/ICH regulations and guidelines /liliAbility to apply advanced statistical techniques and interpret complex analysesStrong presentation and communication skills /liliExperience leading teams of SAS programmers and statisticians /liliAbility to consult with investigators and define analysis strategies /li /ul /p #J-18808-Ljbffr