Senior Director, Biostatistics

Senior Director of BiostatisticsRemote – United StatesAbout the PositionA leading AI-driven pharmaceutical company is seeking a Senior Director (program lead) of Biostatistics to join its team. The successful candidate will lead all biostatistics activities for a program, applying innovative quantitative approaches to clinical trial design and analysis. This role will collaborate with Biometrics leadership and the technology team to develop and implement tools for clinical trial design and simulation.ResponsibilitiesLead statistical strategy and technical activities for a key program.Oversee all statistical activities related to study design, study execution, data interpretation, and regulatory submissions.Develop study designs that align with clinical development plans and regulatory approval pathways.Conduct quantitative evaluations of study designs and clinical development options using simulation studies.Collaborate with cross-functional teams to develop regulatory documents and attend regulatory meetings.Ensure statistical reporting compliance, including protocol reviews, statistical analysis plans, study result reports, clinical study reports, and publications.Oversee CRO / vendor activities to ensure GCP compliance and adherence to relevant protocols and industry standards.Support the development and implementation of tools for clinical trial design and simulation.Required QualificationsM.S. or Ph.D. in Statistics or Biostatistics.At least 8 years of relevant experience in the pharmaceutical and / or biotechnology industry with an M.S., or at least 6 years with a Ph.D.Deep understanding of statistical designs and methodologies for early and / or late-stage development programs.Passion for quantitative decision-making and experience evaluating clinical trial designs via simulation.Expertise in frequentist or Bayesian approaches to study design and decision-making.Ability to communicate complex statistical analyses to cross-functional teams effectively.Solid understanding of ICH guidelines for study design and data analysis.Experience in clinical trial execution, including protocol development, SAP development, and clinical study reporting.Regulatory experience, including interactions with agencies such as FDA and EMA, with prior contributions to an NDA / BLA submission.Proficiency in statistical software such as SAS, R, EAST, and FACTS.Strong R programming skills; expert-level proficiency is preferred.This position offers an opportunity to contribute to groundbreaking biostatistical research and help accelerate drug development. If you are passionate about innovative trial design and statistical methodologies, we encourage you to apply. Please contact Bria Gaber or Tyler Abrams for more information.#J-18808-Ljbffr