Senior Biostatistician
Tasks
- Contribute to study design and statistical analysis approaches
- Develop and review protocols and statistical analysis plans
- Ensure deliverables meet timelines SOPs regulatory requirements and quality standards
- Interpret statistical results and communicate insights
- Mentor junior statisticians and improve processes
- Provide statistical guidance throughout clinical trial lifecycle
- Review ADaM specifications and analysis datasets
- Review statistical outputs tables listings figures
- Support Data Monitoring Committee activities
- Support clinical trials from initiation to regulatory submission
- Support interim analyses safety reviews and efficacy assessments
- Support oncology analyses time to event endpoints subgroup and sensitivity analyses
- Support responses to sponsor inquiries and health authority questions
Perks/Benefits
- 401k retirement plan
- Annual corporate holidays
- Dental insurance
- Employee assistance program
- Employee discounts
- Health advocacy services
- Medical insurance
- Paid sick leave
- Paid vacation time
- Remote work flexibility
- Vision insurance
- Wellness resources
Skills/Tech-stack
ADaM | Analysis planning | Biostatistics | CDISC | Categorical Data | Categorical data analysis | Clinical Trial Methodology | Clinical trial | Data Analysis | Data Monitoring | Data Monitoring Committee | Event analysis | ICH GCP | IRECIST | Longitudinal data | Longitudinal data analysis | R | RECIST | Randomization | Regulatory Reporting | SAS | SDTM | Sample Size | Sample Size Calculation | Sensitivity Analysis | Statistical Analysis | Statistical Analysis Planning | Study design | Subgroup Analysis | Survival analysis | Time to Event | Time to event analysis | Trial methodology
Education
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