Senior Director, Biostatistics
Cambridge, MA, United States
USD 136K-170K (estimate) Senior-level Full Time
Tasks
- Author clinical study reports statistical methods and interpretation
- Author statistics sections of clinical protocols
- Contribute to data monitoring committee documents
- Design randomization schedules and test randomization lists
- Develop and implement SOPs
- Develop shells for tables figures and listings
- Develop statistical analysis plans and integrated summaries
- Drive confirmatory and exploratory analytics operating model
- Establish governance for exploratory analytics
- Lead biometrics process improvement
- Lead rapid response analytical efforts
- Lead statistical aspects of clinical development programs
- Optimize statistical methods for study design analysis and reporting
- Oversee biostatistics and biometrics team leadership
- Oversee planning and execution of biometrics deliverables
- Partner with clinical development medical affairs and regulatory teams
- Perform ad hoc exploratory statistical analyses
- Provide statistical strategy for clinical development
- Respond to FDA EMA and regulatory agency comments
- Review case report form designs
- Support IND NDA MAA statistical activities
- Support publication materials
- Use R Python and interactive visualization with SAS workflows
Perks/Benefits
- Caregiver support
- Emotional wellness resources
- Financial wellness resources
- Physical wellness resources
- Work-life balance support
Skills/Tech-stack
ADaM | Analysis Plan | Bayesian statistics | Biostatistics | CRO Management | Causal Inference | Clinical Trial Design | Clinical trial | Clinical trials | Data Monitoring | Data Monitoring Committee | EMA regulations | External Control | External control arms | FDA Regulations | Frequentist Statistics | ICH Guidelines | Integrated Summary | Integrated Summary of Effectiveness | Integrated Summary of Safety | Python | R | Randomization | Real-World Data | Risk-based | Risk-based validation | S&OP | SAS | SDTM | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Trial design
Education
Regions
Countries
States
Cities
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