Principal Biostatistician Medical Affairs ( UK, Ireland, Poland, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, Netherlands)
GBR-Remote, United Kingdom
R
GBP 78K-91K (estimate) Senior-level Full Time
Tasks
- Analyze observational studies
- Attend regulatory agency meetings
- Coach and mentor biostatistics staff
- Conduct exploratory analysis
- Conduct independent review of biostatistics work
- Coordinate biostatistics and statistical programming activities
- Create or review analysis dataset specifications
- Create or review tables listings figures specifications
- Develop tables listings figures mockups
- Ensure compliance with SOPs and ICH guidelines
- Generate randomization schedule
- Interface with project team stakeholders
- Maintain project documentation and quality control documents
- Participate in data monitoring committee activities
- Participate in data safety monitoring board activities
- Perform verification and quality control
- Prepare statistical analysis plans
- Provide statistical support to medical affairs
- Represent biostatistics on project teams
- Review SAS annotated case report forms
- Review database design
- Support integrated analyses
- Support proposals and budgets
- Support protocol statistical aspects
- Support real-world evidence studies
Perks/Benefits
Skills/Tech-stack
Analysis Plan | Case Report Form | Data Monitoring | Data Monitoring Committee | Data Safety | Data Safety Monitoring Board | Data safety monitoring | Database Design | Exploratory analysis | ICH | Integrated Analysis | Observational studies | Quality Control | Randomization | Real-World Evidence | SAS | SOPs | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Tables Listings Figures
Education
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