BACKGROUND

RESPONSIBILITIES

• Leads the statistical analysis of pharmaceutical product development, to include analyzing correlates of immunity and product efficacy, for inclusion in IND amendments to the FDA
• Supports multiple functional areas, including 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 and client, orally and in writing
• Provides leadership and work guidance to less experienced personnel

REQUIREMENTS

• Master's degree in statistics or mathematics, with a PhD in statistics or mathematics preferred
• Eight or more years of experience in statistical analysis using SAS, with at least three years in the biotechnology/pharmaceutical field, including validation work. Prior experience managing subcontractors preferred.
• Experience working with company used databases, statistical software packages and operating systems
• Experience working with metrics tools and processes
• Experience working with statistical, data-collection and test development procedures

• Personal computer and industry standard statistical analysis tools skills
• Strong analytical and problem solving skills
• Strong communication skills for gathering and presenting test results to individuals and groups
• Leadership skills to guide and mentor the work of less experienced personnel
• Ability to work independently and as part of a team

• High skill level with SAS software
• Ability to describe statistical approaches and analyses clearly to non-statisticians and clients
• Experience with both traditional and Bayesian statistical methods

LOCALE

HOW TO APPLY