Statistical Scientist Director

Premier Research is looking for a Statistical Scientist Director to join our Biostatistics team.You will help biotech, medtech, and specialty pharma companies transform life?changing ideas and breakthrough science into new medicines, devices, and diagnostics.We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.Serve as lead statistician on complex, key client studies, acting as point?of?contact, ensuring cohesive communication with sponsors and internal teams, and leading project?level statistical strategy from protocol/SAP planning through reporting, ensuring alignment of design, analyses, and data interpretation.Develop or provide senior oversight for statistical deliverables, including: statistical selection of protocols, statistical analysis plans (SAPs), randomization specifications and statistical contributions to CSRs, publications, and regulatory documents.Identify risks related to study design, sample size, or analysis approaches and proactively propose mitigation strategies.Act as project manager for biostatistics stand?alone work and drive high?quality statistical deliverables while managing budget, scope, and timeline expectations.Advise clients on regulatory guidelines, statistical principles for submissions, and global expectations (FDA, EMA, PMDA, etc.).Advanced degree (MS or PhD) from accredited college or university in statistics or closely related field; equivalent combination of education, training and experience will be considered.~15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment.~ At least 1 yr technical experience in clinical trials design and analysis implementing innovative statistical analysis.~ Strong knowledge of regulatory, scientific, technical and clinical expertise in conduct of clinical trials in the respective area of focus as demonstrated by past positions related to the therapeutic area in the CRO and Pharma/Biotech sector.~ Strong computer skills, with knowledge of advanced programming skills with standard software, including SAS, R. ~ Excellent working knowledge of CDISC standards and application of these standards to projects.~ Ability to manage and de?escalate difficult situations with clients, teams, and management.~ Excellent English and Host Country communication skills (verbal, written & interpersonal).~ Excellent organizational and time?management skills, able to prioritize work to handle multiple tasks and meet deadlines in a dynamic environment.~

Advanced degree (MS or PhD) from accredited college or university in statistics or closely related field; equivalent combination of education, training and experience will be considered. ~15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment. ~ At least 1 yr technical experience in clinical trials design and analysis implementing innovative statistical analysis. ~ Strong knowledge of regulatory, scientific, technical and clinical expertise in conduct of clinical trials in the respective area of focus as demonstrated by past positions related to the therapeutic area in the CRO and Pharma/Biotech sector. ~ Strong computer skills, with knowledge of advanced programming skills with standard software, including SAS, R. ~ Excellent working knowledge of CDISC standards and application of these standards to projects. ~ Ability to manage and de?escalate difficult situations with clients, teams, and management. ~ Excellent English and Host Country communication skills (verbal, written & interpersonal). ~ Excellent organizational and time?management skills, able to prioritize work to handle multiple tasks and meet deadlines in a dynamic environment.