Senior Biostatistician
Virtual United States North Carolina, United States
R
USD 87K-173K Senior-level Full Time
Tasks
- Contribute to manuscripts and presentations
- Design clinical trial statistics
- Develop ADaM datasets
- Develop SDTM datasets
- Develop derived datasets
- Develop randomization methodology
- Develop statistical design analysis policies
- Extract trial data summaries
- Format report documents and tabulations
- Identify system process improvements
- Maintain program documentation
- Manage statistical project support
- Prepare final reports
- Produce ad hoc data summaries
- Produce tables, listings, figures
- Provide statistical consultancy
- Review analysis plans
- Review study designs
- Review study reports
- Run and test SAS programs
- Specify and review tables figures listings shells
- Support bidding and proposal activities
- Support quality assurance and audits
- Test and validate SAS macros
- Validate datasets and outputs
- Write Statistical Analysis Plans
- Write and review derived dataset specifications
- Write and validate SAS programs
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR Part 11 | ADaM | Analysis Plans | Audit Support | CDISC SDTM | CFR Part 11 | Clinical Data Interchange Standards | Clinical Data Interchange Standards Consortium | Clinical Trial Data | Clinical Trial Data Processing | Clinical data | Clinical trial | Data Processing | Data Validation | Data extraction | Derived Datasets | FDA 21 CFR | FDA 21 CFR Part 11 | ICH | NQuery | Part 11 | Quality Assurance | Randomization | Regulatory Compliance | SAS | SAS Macros | Statistical Analysis | Study protocols | Tables figures listings
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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