Provide statistically rigorous expertise including hands on development on study design, statistical analysis plans, communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects; Accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects; Write Statistical Analysis Plans including mock TFLs for studies and cross study integrated analyses; Partner closely with Data Management on eCRF and DB design, data cleaning and activities to support in stream data cleaning, freezing/locking subjects and database lock; Partner closely with Statistical Programming to draft SDTM/ADaM specifications, QC datasets and tables, listings and figures
Requirements:
Advanced degree in statistics or biostatistics; PhD preferred; A minimum of 8-12 years of experience in Pharma/Biotech designing phase 1-4 clinical trials, analyzing and reporting clinical trial data; A minimum of 8-12 years of experience in R and SAS programming including R packages, graphics (e.g. waterfall, spider, box plots, forest plots, etc) in a clinical trials setting; A minimum of 6 years of experience in oncology including regulatory submission experience for oncology medicines; Strong technical and statistical expertise including interim analyses, Bayesian approaches, mixed models, survival analysis methods, etc; expertise in statistical software tools, e.g. EAST
Text:
Dir/Sr. Director, Biostatistics Provide statistically rigorous expertise including hands on development on study design, statistical analysis plans, communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects; Accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects; Write Statistical Analysis Plans including mock TFLs for studies and cross study integrated analyses; Partner closely with Data Management on eCRF and DB design, data cleaning and activities to support in stream data cleaning, freezing/locking subjects and database lock; Partner closely with Statistical Programming to draft SDTM/ADaM specifications, QC datasets and tables, listings and figures Advanced degree in statistics or biostatistics; PhD preferred; A minimum of 8-12 years of experience in Pharma/Biotech designing phase 1-4 clinical trials, analyzing and reporting clinical trial data; A minimum of 8-12 years of experience in R and SAS programming including R packages, graphics (e.g. waterfall, spider, box plots, forest plots, etc) in a clinical trials setting; A minimum of 6 years of experience in oncology including regulatory submission experience for oncology medicines; Strong technical and statistical expertise including interim analyses, Bayesian approaches, mixed models, survival analysis methods, etc; expertise in statistical software tools, e.g. EAST
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