Senior Associate Director, Biostatistics – Oncology (Remote)

Essential Functions: Participate in or lead department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols. Lead, develop and execute statistical strategy, design, and analyses for clinical trials within a project(s) Develop or review statistical analysis plans and interpret data. Develop statistical programs as necessaryto simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices. Attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies. Collaborate with researchers and thought leaders to plan clinical development projects and, if appropriate, publications of study results. Present study results to internal and external audiences Be able to conduct independent research and resolve statistical methodological issues Recruit, develop and supervise internal and external statisticians. Required Knowledge, Skills, and Abilities Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis. Good knowledge and experience working in Oncology therapeutic area Experience in using SAS or R; knowledge of other statistical applications and programming languages a plus. Thorough knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards. Able to work in a fast-paced, flexible, team-oriented environment. Possess excellent interpersonal and communication skills (written and verbal). Strong attention to detail. Flexible, positive, creative thinker, good communicator. Work without close supervision. Time management skills are important. Required/Preferred Education and Licenses PhD with >4years of experience or MS with >6years of experience Degree in statistics, mathematics, or a related discipline with a statistical focus. Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials. Expert knowledge of drug development regulations pertinent to statistical analysis. Knowledge of the oncology or hematology therapeutic area is preferred. Bayesian and adaptive design experience is preferred. Experience in contributing to NDA or BLA submissions and defense. Proficient SAS programming skills, comprehensive understanding of CDISC models and standards. Excellent writing and communication skills, d emonstrated leadership abilities and excellent interpersonal skills #LI-Remote #LI-DM1