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
Text:
Lead Statistician 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 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
Please click here, if the job didn't load correctly.
Please wait. You are being redirected to the job in 3 seconds.
