Principal Biostatistician - Remote
Tasks
- Apply drug development knowledge to statistical analyses
- Create randomization and kit schedules
- Develop statistical analysis plan and interim statistical analysis plan text and shells
- Lead complex clinical research projects programs and submissions
- Manage client meetings and sponsor communications
- Perform sample size calculations
- Prepare and review statistical methods and results for CSR
- Review and develop ADAM specifications
- Review and develop statistical section of sponsor protocol
- Stay current with industry practices and regulatory guidelines
- Support DSMB by preparing and presenting unblinded statistical output
- Support regulatory submission requirements
- Use SCM tools checks in out and SharePoint
- Write white papers and blogs
Perks/Benefits
- Career development
- Great Place to Work certified
- Inclusive work environment
- Remote work
- Supportive team
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | Analysis Plan | Biostatistics | CFR Part 11 | Clinical Practice | Clinical trials | DSM B | FDA | Good Clinical Practice | IBM SPSS | ISO 27001 | ISO 9001 | Interim Statistical Analysis Plan | Part 11 | Randomization | SAS | SCM | SQC | Sample Size | Sample Size Calculation | SharePoint | Statistical Analysis | Statistical Analysis Plan | Statistical programming
Education
Roles
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