Director Of Biostatistics

Job DetailExperience Level DirectorDegree Type Doctor of Philosophy (PhD)Employment Full TimeWorking Type HybridJob Reference 0000018068Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Drive impactful biostatistical strategies for late-phase clinical programs. Collaborate on innovative trials and regulatory submissions in a hybrid setting. Enhance expertise in advanced methodologies and leadership opportunities.Job DescriptionOverviewLead biostatistical strategies for late-phase clinical development programs, ensuring innovative trial designs and regulatory compliance.Collaborate with multidisciplinary teams to develop clinical protocols and statistical analysis plans.Provide expertise in advanced statistical methodologies to support regulatory submissions and scientific publications.Drive innovation and quality in statistical analysis and trial design processes.Contribute to strategic planning and clinical development initiatives within a dynamic environment.Engage with regulatory authorities and stakeholders to represent statistical perspectives effectively.Mentor and guide teams in statistical programming and data analysis techniques.Support global regulatory submissions with comprehensive statistical expertise.Promote collaboration and teamwork within the biostatistics department.Key Responsibilities & DutiesDesign and implement innovative clinical trials, authoring statistical sections of protocols.Prepare and oversee statistical analysis plans, ensuring accurate implementation.Collaborate with clinical teams to ensure quality in trial execution and data management.Provide statistical guidance on trial conduct and data interpretation.Lead biostatistics support for regulatory submissions and scientific publications.Engage with regulators and stakeholders to present statistical findings and insights.Develop and review eCRFs, stratification schemas, and randomization plans.Contribute to clinical study reports and regulatory documentation.Mentor teams in statistical programming and advanced methodologies.Job RequirementsPh.D. in Statistics, Biostatistics, or equivalent with 8-10 years of pharmaceutical statistics experience.Proficiency in SAS and R programming languages, with a strong statistical foundation.Experience designing and supporting late-phase clinical studies and regulatory submissions.Knowledge of Bayesian and adaptive clinical trial designs.Strong communication and presentation skills to effectively convey statistical insights.Experience with clinical trial simulations and decision criteria evaluation.Interest in biology and biological processes, including RNAi technologies.Proven ability to interact with regulatory authorities and stakeholders.Leadership experience in biostatistics within pharmaceutical settings.