Duties: Lead the statistical strategy for projects and participate as a core member on clinical study teams; Be accountable and responsible for the statistical design, analysis plans, reporting (including development of ADaM specifications/datasets) and interpretation of Phase 1-4 clinical trials including integrated analyses across trials; Initiate, drive and implement novel methods and innovative trial designs; Provide statistical input into protocol and case report form (CRF) development (e.g., trial design, sample size estimation, statistical methods for protocols, edit checks for clinical trial data); Participate in regulatory (e.g., pre-IND, NDA) activities including authoring of statistical sections and participating in regulatory meetings/written responses
Requirements: PhD in Biostatistics or Statistics with ≥ 4 years of pharmaceutical or CRO industry experience (MS candidates with significant related experience may be considered); Experience in design and reporting of Phase 1-3 clinical trials; Deep and broad statistical training and experience in methodologies such as Mixed Models, Bayesian adaptive designs, Interim Analyses including Futility, Modelling and Simulation methods, and in SAS, R; Experience writing statistical analysis plans and mock TFLs for clinical study reporting