Principal Biostatistician (Remote)
Bridgewater, New Jersey, United States
R
USD 150K-200K Senior-level Full Time
Tasks
- Collaborate with interdisciplinary teams for drug development
- Conduct peer review of SAPs and technical documents
- Conduct quality control on ADaM datasets
- Develop and review Statistical Analysis Plans
- Develop sample size estimation and statistical analysis planning
- Ensure compliance with regulatory requirements and standards
- Lead statistical oversight for clinical trial programs
- Manage statistical and programming resources and capacity
- Manage statistical operations with project teams
- Perform quality control on statistical deliverables
- Perform statistical modeling and data analysis
- Provide statistical consultation for publication materials
- Provide statistical input to protocol design
- Review ADaM dataset specifications
- Support eCRF and data review deliverables
- Support regulatory submissions and agency interactions
- Validate statistical tables listings and figures
- Write statistical reports and statistical methodology sections
- Write trial protocols and research proposals
Perks/Benefits
Skills/Tech-stack
ADaM | Analysis Plan | Analysis reporting | Biostatistics | CDISC | Clinical trials | Data Review Plan | Data Validation | Data review | ECRF | Quality Control | Regulatory Compliance | Sample Size | Sample size estimation | Size estimation | Statistical Analysis | Statistical Analysis Plan | Statistical Analysis Reporting | Statistical Figures | Statistical Listings | Statistical Tables | Statistical modeling
Education
Regions
Countries
States
Cities
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