FSP Principal Biostatistician, Safety
Durham, North Carolina, United States of America
R
USD 105K-294K Senior-level Full Time
Tasks
- Collaborate with project teams on objectives and timelines
- Contribute to clinical study reports and regulatory documents
- Contribute to study design and protocol development
- Develop and review Statistical Analysis Plans
- Develop and review TFL templates
- Guide programmers on analysis dataset specifications
- Interpret study results and ensure accuracy
- Monitor project activities and deliverables
- Participate in pre-IND and NDA activities
- Perform exploratory safety analyses
- Present and communicate safety analyses
- Provide statistical expertise to data management and clinical teams
- Provide statistical leadership for safety analyses
- Review CRFs and study documentation
- Serve as unblinded DMC statistician
- Support exploratory analyses
- Validate analysis variables and statistical outputs
- Write statistical sections of clinical trial protocols
Perks/Benefits
- Career trajectory
- Flexible schedules
- Home based remote working
- Long-term engagements
- Redeployment opportunities
- Research opportunities
- Tailored development curriculum
- Technical training
- Work-life balance
Skills/Tech-stack
ADaM | CDASH | CDISC | ICH E9 | ICH GCP | R | SAS | SDTM | Safety Analysis | Statistical Analysis | Statistical programming
Education
N/A
Regions
Countries
States
Cities
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