Description
Key Roles:-Working closely with programmers to provide specifications for report tables and listings
-Coordinating the quality- control checking of deliverables
-Developing systematic documentation of methods, results and statistical programming
-Providing statistical methodology for study protocol, developing statistical analysis plan, and performing statistical analysis
-Working on complex statistical problems, which requires an in-depth evaluation of various factors
- Managing multiple studies in a team setting assuring consistency across studies against respected timelines
-Providing statistical consulting to clinical teams in design and analysis and interpretation of the study data within clinical studies
Required Experience:
-Minimum: 5 years of relevant experience in pharmaceutical or diagnostic company, with 2+ years of managerial experience
-Preferred medical device experience, experience working in a CRO environment and/or Virology, Anti-virals, Anti-infectives, and Microbiology
-Broad knowledge of clinical development: clinical operations, data management and clinical study report preparation workflow
-FDA or European regulatory experience and in-depth knowledge of regulatory regulations and guidelines
-Ability to exercise judgment within broadly defined policies and practices in selecting methods, techniques, and evaluation criteria for obtaining results.
-Familiarity with CLSI guidelines
-Statistical computing in SAS is required
-Thorough knowledge of experimental design, general linear model, categorical data analysis and statistical computing