The incumbent will be expected to exhibit a strong degree of creativity and resourcefulness in applying advanced statistical methodology for assigned drug projects and strong analytic ability. Perform methodological work, conduct exploratory analysis, participate in building data warehouse, develop and prepare manuscripts for presentations conferences and publish papers at peer-reviewed journals. Using incumbent's thorough knowledge of Health Authority statistical guidelines and publication policy provide advise and guide internal and external researchers on appropriate statistical methods and analysis. Interacts with Health Authorities and investigators and defends statistical methodology used within the project. The incumbent oversees and trains junior statisticians and programmers. Perform modeling, simulation, and data mining for the assigned drugs. Work with the IT group in developing and implementing the appropriate data warehouse. Some travel may be required.
• The position will be filled at level commensurate with experience. Ph.D. in Statistics/Biostatistics with at least 5 or more years of clinical trials experience or M.S. in Statistics/Biostatistics with at least 8 years of clinical trials experience.
• Proven knowledge of clinical trial methodology.
• Very good oral and written communication skills.
• Strong statistical skills
• Excellent SAS programming skills, and excellent knowledge of SAS statistical analysis procedures.
• Good S-plus programming skills.
• Demonstrated ability to oversee and guide internal programmers and CRO staff in the preparation of data displays, graphs, and summary tables
• Ability to guide/perform modeling, simulation, meta analysis, and exploratory analyses of data
• Ability to review/prepare written interpretations of statistical results and to integrate these findings into reports and publications
• Strong project management skills
• Knowledge of FDA statistical guidelines
• Knowledge of drug development process