Principal Biostatistician
March 2nd, 2017 by adminPrincipal Biostatistician
Description
As the project statistician for assigned clinical programs, the position represents interests on project teams advising team members in drug development strategies, plans all aspects of data analysis for assigned projects, has responsibility for the preparation and maintenance of the Analysis Plan, and ensures the quality controlled production of all tables, listings and graphs for the clinical document while adhering to the pre specified analyses and timelines. This position interacts with domestic and foreign regulatory agencies for R&D projects. The position may serve on company and/or departmental teams and make recommendations for departmental standards.
Qualifications
- Education or education/experience combination equivalent to a post graduate degree in statistics or statistics related field.
- At least five (5) years of pharmaceutical experience with Ph.D. or Ph.D. equivalent or seven (7) years of pharmaceutical experience with a Master’s Degree or Master’s Degree equivalent.
- Statistical expertise with regard to clinical studies in Design including cross over, multiplicity, interim analyses, non-inferiority, sample size and power.
- Statistical expertise with regard to clinical studies in Analysis including treatment by center interaction, multi center, missing value imputation, covariate, and subpopulations.
- Statistical expertise with regard to clinical studies in Methodology including analysis of variance and mixed linear models, survival analysis, categorical data analysis, reliability, multivariate analysis, robust estimation, nonparametric techniques, and group sequential analyses.
- Solid knowledge in global regulatory guidance documents and requirements.
- Working knowledge of SAS.
For more information, please contact:
Craig Tanner
Tanner & Associates
760 598 3363
