Principal Biostatistician
Tasks
- Conduct electronic regulatory submissions
- Create and follow SOPs and templates
- Create and maintain analysis datasets
- Design interim analysis strategies
- Design randomization procedures
- Develop and review Statistical Analysis Plans
- Develop and review analysis datasets and statistical outputs
- Develop clinical trial protocols and clinical study reports
- Develop data standardization processes
- Ensure dataset traceability reproducibility and validation
- Lead e-submission data preparation
- Lead statistical programming standards and standard programs
- Lead statistical strategy for clinical trials
- Maintain and validate CDISC SDTM and ADaM datasets
- Mentor and train junior biostatisticians
- Oversee DMC activities
- Oversee statistical analysis from study design to regulatory submission
- Perform sample size calculations
- Write statistical methodology sections
Perks/Benefits
- 401k retirement plan with company match
- Employer Assistance Program EAP
- Flexible spending accounts
- Health and financial wellness programs
- Identity theft protection
- Life and AD&D insurance
- Medical, dental and vision plan options
- Paid time off
- Short-term and long-term disability
Skills/Tech-stack
Adaptive trial design | Analysis Plan | Bayesian Methods | Biostatistics | CDISC | CDISC ADaM | CDISC SDTM | Clinical Practice | Clinical Research | Clinical Trial Design | Clinical data | Clinical data management | Clinical trial | DMC Oversight | Data Management | Data Standardization | Data Validation | Data submission | Data traceability | Electronic Data | Electronic data submission | Good Clinical Practice | Interim analysis | Protocol development | Randomization | Regulatory Compliance | SAS | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Statistical Reporting | Statistical programming | Trial design
Education
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