Requires a Doctorate of Public Health DrPH or PhD in Public Health, Biostatistics or a related field and 4 years of biotechpharma experience. In the alternative the employer will accept a Masters in the specified fields and 6 years of biotechpharma experience. Must have experience in SAS, SPlusR, Sample size calculation software e.g., East and nQuery; Meeting timelines for deliverables such as topline results and final analyses; Advanced statistical techniques and interpreting results; Regulatoryresearch guidelines on drug development, GCP, and statistical principles including ICH guidelines; Advanced statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, sequential methods, and strategies for handling missing data; Advanced clinical trial design concepts, such as noninferiority, adaptive methods, typeI error protection, dynamic randomization, and sample size estimation in complex settings; Working in a departmental computing environment and performing advanced statistical analyses; Describing advanced statistical techniques and interpreting results; and Formulating statistical objectives, design, and analyses for complex clinical projects.
Categories: eb3
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