Senior Biostatistician
Raleigh, United States
USD 142K-208K (estimate) Senior-level Full Time
Tasks
- Adapt protocol language to statistical analysis plan
- Attend project team meetings and discuss project issues
- Develop analysis dataset specifications
- Develop programs for statistical review of datasets listings tables and graphs
- Develop randomization specifications and programs
- Interact with internal and external clients
- Maintain biostatistical section of TMF
- Maintain confidentiality and security compliance
- Maintain detailed project time records for billing and budgeting
- Perform sample size calculations and QC
- Perform unblinding activities and update algorithms with unblinded treatment codes
- Prepare draft statistical analysis plans and shells
- Procure sample size operational design information
- QC TLFs SDTM and analysis datasets
- Read and map SDTM and ADaM domains
- Review CSR statistical section accuracy
- Review PD file and update exclusion specifications and programs
- Review data management documents for quality
- Review draft SAP and shells
- Review study design protocol and statistical sections
- Stay current with biostatistics literature and training
- Train junior biostatisticians
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Biostatistics | CDISC | CSR | Clinical Trial Design | Clinical data | Clinical data standards | Clinical trial | Data Management | Data Standards | R | Randomization | SAS | SDTM | Sample Size | Sample Size Calculations | Statistical Analysis | TLF | TMF | Trial design | Unblinding
Education
Regions
Countries
States
Cities
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