Principal Biostatistician
Tasks
- Conduct analyses per statistical analysis plan
- Coordinate ISS ISE submissions
- Develop and maintain SOPs
- Develop statistical analysis plans
- Generate summary tables data listings and figures
- Lead clinical study statistics
- Maintain clinical trial statistical integrity
- Manage biostatistics timelines budgets and expectations
- Mentor junior biostatistics staff
- Perform SAS programming
- Perform post hoc and exploratory analyses
- Perform senior peer review
- Perform statistical QC of deliverables
- Prepare clinical study report statistical sections
- Provide study design statistical expertise
- Represent biostatistics in regulatory meetings
- Review case report forms
- Support client questions with statistical expertise
- Write statistical protocol sections
Perks/Benefits
- Attainable career advances
- Employee recognition program
- Engaging work culture
- Flexible work schedule
- Generous time off
- Positive work/life balance
- Workplace belonging activities
Skills/Tech-stack
Analysis Plans | Case Report Forms | Clinical Data Analysis | Clinical Trial Design | Clinical data | Clinical trial | Data Analysis | Data Integrity | Exploratory Data Analysis | FDA Regulations | ICH GCP | ISE Submissions | ISS Submissions | Post-hoc analysis | Protocol writing | Quality Control | SAS | SAS programming | Statistical Analysis | Statistical analysis plans | Statistical quality | Statistical quality control | Trial design
Education
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