Principal Biostatistician FSP
Tasks
- Collaborate with sponsor cross-functional teams
- Contribute to regulatory submission dossiers
- Develop analysis dataset specifications
- Develop sourcing strategy
- Develop statistical analysis plans
- Develop study designs
- Develop study protocols
- Generate statistical methodologies
- Identify and adapt statistical research methodologies
- Input into case report forms
- Input into data management plans
- Lead electronic submissions
- Manage biostatisticians
- Manage statistical programmers
- Perform ad-hoc analyses
- Perform exploratory analyses
- Perform statistical analyses
- Provide statistical leadership
- Review analysis of study data
- Review study reports
Perks/Benefits
- N/A
Skills/Tech-stack
Ad-Hoc | Ad-hoc analysis | Analysis Plan | CDISC | Case Report Forms | Clinical Efficacy Reporting | Clinical Protocol | Clinical Protocol Development | Clinical Safety | Clinical Safety Reporting | Clinical trials | Data Management | Data management plans | Electronic submissions | Exploratory analysis | Matrix Management | Protocol development | R | Regulatory Interactions | Regulatory guidelines | SAS | Safety reporting | Statistical Analysis | Statistical Analysis Plan | Statistical modeling | Study design
Education
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