Senior Biostatistician

Tasks

• Address peer statistician review comments
• Analyze data for publications abstracts manuscripts and posters
• Archive study files
• Assess and report data quality issues
• Assist with database lock
• Conduct statistical dry runs and final runs
• Contribute to clinical study report statistical sections
• Contribute to data validation specification
• Create statistical quality control and quality assurance plans
• Develop and review ADaM dataset specifications
• Develop randomization specifications and codes
• Lead statistical programming issues and resolutions
• Manage assigned clinical trial projects
• Perform QC validation of analysis datasets and TLGs
• Perform sample size calculations
• Perform statistical analysis per statistical analysis plan
• Provide statistical expertise for clinical trial design and analysis
• Provide statistical input to CRF design and database variable structures
• Provide statistical input to data collection methods
• Review SDTM dataset specifications
• Specify and program database quality acceptance checks
• Support trial results reporting and dissemination meetings
• Validate core statistical results
• Write Statistical Analysis Plans
• Write statistical report sections of clinical study report
• Write statistical sections of study protocols

Perks/Benefits

• Remote work
• Work from home

Skills/Tech-stack

ADaM | Analysis Plan | Case Report Form | Clinical study | Clinical study report | Clinical trial | Clinical trial analysis | Data Validation | Dry Run | QC validation | Randomization | SDTM | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Trial Analysis