Description
Day to Day Responsibilities:- Conduct clinical trial design and statistical analysis for multiple therapeutic areas
- Perform pharmacokinetic modeling (individual and population PK) of large molecule pharmacokinetics; conduct statistical analysis using SAS (proc mixed, bioequivalence, GEE model, simulation for power assessment)
- Liaise with other scientists regarding analysis plans
- Design clinical trials and interact with clinical investigators and other experts to determine appropriate statistical analysis to answer research questions
- Apply appropriate statistical models to simulate study design
- Evaluate databases and statistical analyses programs and interact with external groups to assess hardware/software compatibility
- Prepare responses to regulatory agency questions regarding statistical aspects of clinical trials
- Participate in qualification audits of external vendors
- Maintain expertise in state-of-the-art biometric modeling, statistical analyses; prepare data analysis plans.
Qualifications
Ph.D. in biostatistics, statistics, or mathematics with emphasis in statistics and 3 years related experience.