Regulatory Biostatistician
Tasks
- Advise data management on database design and validation
- Collaborate on statistical suitability and regulatory compliance
- Create table specifications and shells
- Develop analysis plans
- Develop standard operating procedures and process documents
- Develop statistical methods sections
- Draft statistical analysis plan documents
- Implement SAS programming for analysis files
- Interpret analyses and write statistical report sections
- Perform consistency checks for tables listings and figures
- Perform data review and statistical analyses
- Perform sample size calculations
- Prepare integrated report statistical content
- Provide regulatory biostatistical support
- Review study case report forms
Perks/Benefits
- 401k match
- Dental insurance
- Disability insurance
- Health insurance
- Life insurance
- Paid Holidays
- Paid time off
- Tuition reimbursement
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | 21 CFR Part 58 | Analysis Plan | Biostatistics | CFR Part 11 | Clinical Practice | Clinical Research | Clinical data | Clinical data management | Consistency Checks | Data Management | Data Validation | Data review | FDA | Good Clinical Practice | Good Laboratory Practice | Integrated Reports | Laboratory practice | Part 11 | Preclinical research | SAS | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Table Specifications
Education
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