FSP Principal Biostatistician, Safety Analytics
Durham, North Carolina, United States of America
R
USD 111K-309K Senior-level Full Time
Tasks
- Collaborate with Data Management, Clinical Development, and Clinical Operations
- Collaborate with multidisciplinary project teams on objectives and timelines
- Contribute to clinical study reports and regulatory documents
- Deliver patient profile display for hepatic safety areas
- Develop and review statistical analysis plans and TFL templates
- Interpret study results and review accuracy
- Investigate root cause issues in analysis outputs
- Monitor project activities timelines deliverables and resource availability
- Perform exploratory safety analyses
- Present and communicate safety analyses
- Present safety analyses to study teams
- Provide statistical leadership for safety analyses
- Review ADaM TFL interactive packages for safety analytics
- Review CRFs and study documentation for statistical safety
- Serve as unblinded DMC statistician
- Supervise programmers on analysis dataset specifications and programming validation
- Support pre IND and NDA activities
- Support safety analytics ADaM TFL development
- Support study design including protocol development
- Validate analysis variables and statistical outputs
- Write statistical sections of clinical trial protocols
Perks/Benefits
- Career trajectory
- Engaging fast paced environment
- Flexible schedules
- Home based remote working opportunities
- Job stability
- Long-term engagements
- Redeployment opportunities
- Research opportunities
- Tailored development curriculum
- Technical training
- Work-life balance
Skills/Tech-stack
ADaM | Analysis Plan | Biostatistics | CDASH | CDISC | Data Analysis | Exploratory Data Analysis | ICH E9 | ICH GCP | Interactive Reporting | R | SAS | SDTM | Safety Analytics | Statistical Analysis | Statistical Analysis Plan | TFL
Education
Regions
Countries
States
Cities
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