Biostatistician, Regulatory Submissions
Tasks
- Apply biostatistical methods
- Communicate analytical findings
- Develop TLFs
- Develop programming standards
- Ensure reproducible analytical outputs
- Guide clinical trial design
- Integrate and clean clinical data
- Manage ADaM development
- Manage SDTM development
- Manage statistical analysis teams
- Oversee statistical analysis plan implementation
- Support business development
- Support regulatory submissions
- Support research dissemination
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Analysis Plan | Biostatistics | Clinical Trial Design | Clinical trial | Data Management | Data Transformation | Data cleaning | EMA | FDA | PAES | PASS | Phase IV | Real-World Evidence | Regulatory Submissions | SDTM | Statistical Analysis | Statistical Analysis Plan | Statistical programming | TLF | Trial design
Education
Roles
Regions
Countries
States
Cities
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