Senior Biostatistician
Tasks
- Advise sponsors on FDA data analytical and filing requirements
- Author briefing book and briefing package sections
- Author statistical sections for study documents
- Communicate analysis results to sponsors and investigators
- Contribute to biostatistics standard operating procedures
- Create TMF data documentation components
- Create regulatory submission databases
- Design clinical research projects
- Ensure accurate timely communication of issues and progress
- Investigate adaptive design approaches
- Lead statistical analysis for clinical trials
- Oversee train and mentor team members
- Perform statistical analyses of clinical research data
- Represent sponsors at FDA meetings
- Respond to regulatory information requests
- Support budgets proposals and business development
- Use SAS and R for advanced statistical methodologies
- Verify distributional assumptions
Perks/Benefits
- 401k
- Bereavement leave
- Dental insurance
- Disability insurance
- EAP
- FSA
- HSA
- Holidays
- Life insurance
- Medical insurance
- Paid time off
- Parental leave
- Remote work
- Vision insurance
- Work-life balance
Skills/Tech-stack
Adaptive Design | Biostatistics | Clinical trials | Data Analysis | Data Documentation | Database Design | FDA Submissions | Imputation | Longitudinal data | Longitudinal data analysis | Missing Data Analysis | Missing data | Poisson regression | R | Regulatory Submissions | SAS | Statistical Analysis | Statistics | Survival analysis | TMF
Education
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