Senior Biostatistician

Tasks

• Address QC review comments
• Address peer statistician review comments
• Analyze publications including abstracts and manuscripts
• Archive study files
• Assess and report data quality issues
• Assist data management with database lock
• Complete required training
• Contribute to Clinical Study Report deviation descriptions
• Create statistical quality assurance plans
• Create statistical quality control plans
• Develop randomization codes
• Develop randomization specifications
• Generate randomization codes
• Lead statistical dry runs
• Lead statistical final runs
• Manage clinical trial projects
• Perform QC validation of TLGs
• Perform QC validation of analysis datasets
• Perform sample size calculation
• Perform statistical analysis per SAP
• Perform third level review of dry runs
• Perform third level review of final runs
• Plan trial results reporting meetings
• Provide input to SDTM dataset specifications
• Provide statistical expertise for study design and analysis
• Provide statistical input to case report form design
• Provide statistical input to variable structure
• Resolve statistical and programming issues
• Review ADaM dataset specifications
• Review Clinical Study Report statistical interpretation
• Review data validation specification input
• Specify database quality acceptance checks
• Validate core results statistically
• Write Statistical Analysis Plans
• Write analysis reviewer guide input
• Write statistical sections of Clinical Study Report
• Write statistical sections of study protocols

Perks/Benefits

• Work from home

Skills/Tech-stack

ADaM | Analysis Plan | Case Report Form | Clinical study report | Clinical trials | Data Management | Data Validation | Dry Run | Project Management | Protocol Deviations | QC validation | R | Randomization | SAS | SDTM | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | TLG