Statistical Scientist Director

OverviewAs Statistical Scientist Director, you will lead statistical strategy for key client studies, acting as primary liaison among sponsors and internal teams. You will shape design, analyses, and interpretation, and oversee statistical deliverables from protocol planning to reporting. You’ll translate complex quantitative concepts for non-statistical stakeholders and contribute to regulatory documents and publications. This role blends leadership, innovative design, and cross-functional collaboration to advance medical innovation. You will guide teams, mentor colleagues, and drive high-impact outcomes for patients and sponsors.Compensaciones / Beneficios flexible work arrangementsgrowth opportunities and mentorshipbalance with life requirementsopportunity to contribute to life-saving therapiestravel opportunities (~20%)collaborative, impact-driven cultureResponsabilidadesLead statistician on complex client studies and drive project-level statistical strategy from protocol/SAP planning through reportingCommunicate quantitative concepts clearly to non-statistical stakeholders including sponsor leadership and regulatory representativesProvide statistical input to Clinical Trial Reports and ProtocolsDevelop sample size, modeling approaches, adaptive or Bayesian trial designsOversee preparation of SAPs, randomization specifications, and statistical contributions to CSRs and regulatory documentsCollaborate with statistical programmers to ensure correct method implementation and interpretationIndependently develop SAS/R programs as neededIdentify design/analysis risks and propose mitigation strategiesAct as project manager for biostatistics work, managing budget, scope, and timelinesEnsure cross-project statistical consistency and contribute to portfolio-level strategyAdvise on regulatory guidelines and global expectations for submissionsSupport business development through bid defenses and capabilities presentationsProvide internal consultancy on statistical issues and champion innovative methodologiesMentor team members and support departmental training and SOPsAct as biostatistician on DSMBs/DMCsPerform other duties as assignedRequisitos principales 15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment1+ year of technical experience in innovative statistical designs in trialsStrong knowledge of regulatory, scientific, technical and clinical aspects in clinical trials within relevant therapeutic areasStrong programming skills in SAS and RExcellent working knowledge of CDISC standards and applicationAbility to communicate statistical concepts to scientists and non-scientistsExperience interacting with regulatory agencies (FDA, EMA, etc.)Proven ability to manage difficult stakeholder situations and ethical, data-driven decision makingExcellent English and host country communication skillsWillingness to travel (~20%)clear communicationleadership and mentoringstakeholder managementSASRCDISC standards

Requisitos principales 15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment 1+ year of technical experience in innovative statistical designs in trials Strong knowledge of regulatory, scientific, technical and clinical aspects in clinical trials within relevant therapeutic areas Strong programming skills in SAS and R Excellent working knowledge of CDISC standards and application Ability to communicate statistical concepts to scientists and non-scientists Experience interacting with regulatory agencies (FDA, EMA, etc.) Proven ability to manage difficult stakeholder situations and ethical, data-driven decision making Excellent English and host country communication skills Willingness to travel (~20%) clear communication leadership and mentoring stakeholder management SAS R CDISC standards