Associate Principal Biostatistician Clinical Safety Statistics (CSS)
USA - Pennsylvania - North Wales (Upper Gwynedd), United States
USD 142K-224K Mid-level Full Time
Tasks
- Assess available software for planned analyses
- Collaborate with risk management safety teams on safety data evaluation planning and execution
- Design develop and evaluate processes methodology and tools for safety evaluation
- Design develop and evaluate safety data evaluation processes methods and tools
- Develop novel statistical methods or programming when needed
- Participate in research for innovative clinical safety statistical methods and applications
- Perform safety evaluation across drug and vaccine development phases
- Prepare reports presentations and statistical graphics for project teams management regulators and investigators
- Provide statistical support and leadership for clinical safety data evaluation
- Stay current on regulatory guidance for safety data evaluation
- Support aggregate safety evaluations for clinical trials regulatory documents and safety inquiries
Perks/Benefits
- 401k
- Annual bonus
- Compassionate days
- Dental insurance
- Long-term incentive
- Medical insurance
- Paid Holidays
- Retirement benefits
- Sick days
- Vacation
- Vision insurance
Skills/Tech-stack
ADaM | Bayesian analysis | Biostatistics | Clinical Trial Design | Clinical trial | Data Analysis | Data Processing | Epidemiology | Integrated safety data | Meta-Analysis | R | R Shiny | Regulatory Compliance | Regulatory documents | SAS | SDTM | Safety Data Analysis | Safety data | Safety database | Safety signal evaluation | Signal evaluation | Statistical Analysis | Statistical graphics | Statistical programming | Survival analysis | Trial design
Education
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