12.High skill level with SAS software
13.Ability to describe statistical approaches and analyses clearly to non-statisticians and clients
14.Experience with both traditional and Bayesian statistical methods
Leads the statistical analysis of DynPort Vaccine Company's pharmaceutical product development, to include analyzing correlates of immunity for vaccines and product efficacy.
Supports multiple functional areas, including product and assay development, manufacturing, nonclinical and clinical research.
Defines methods of analysis and data requirements and designs data collection/quality assurance methods ensuring that relevant information is obtained and controlled according to legal and company guidelines.
Reviews statements of work and writes the statistical analysis sections to ensure sufficient power is obtained with the study design.
Reviews clinical statistical analysis plans and evaluates population size needed to meet endpoints with sufficient power.
Reviews work performed by statistical subcontractors.
Applies statistical methodology to analyze and interpret statistical data and organizes results to ensure that all facets of data collection and interpretation meet client specifications.
Recommends course of action or appropriate interpretation(s).
Prepares conclusions and predictions based on data summaries and advises clients on benefits and limitations of statistical processes adopted in data collection and analysis to ensure that clients use information to make informed decisions.
Conducts research to determine appropriate approach and methodology for analyses.
Develops rules, benchmarks, etc. for the analysis and interpretation of model data.
Clearly communicates the rationale for analyses and the outcomes to internal team, client and regulatory agencies, orally and in writing.
Provides leadership and work guidance to less experienced personnel.