|Seeking a US Military Veteran, National Guardsman, Reservist, and/or Military Spouse to apply for a Senior Statistician Advisor. Lead statistical analysis of pharmaceutical product development, and analyze correlate of immunity for vaccines and product efficacy. Position requires Master’s in statistics or mathematics (PhD preferred), 8+ years in statistical analysis, with 3 in biotechnology/pharmaceutical field, using both traditional and Bayesian statistical methods.
Responsibilities: Veteran Military
- Lead statistical analysis of pharmaceutical product development, analyze correlate of immunity for vaccines and product efficacy. Provide leadership and work guidance to less experienced personnel.
- Support multiple functional areas, product and assay development, manufacturing, plus nonclinical and clinical research.
- Define methods of analysis and data requirements and design data collection/quality assurance methods to ensure that relevant information is obtained and controlled according to legal and company guidelines.
- Review statements of work and write statistical analysis sections to ensure sufficient power is obtained with study design.
- Review clinical statistical analysis plans and evaluate population size needed to meet endpoints with sufficient power. Review work performed by statistical subcontractors.
- Apply statistical methodology to analyze and interpret statistical data and organizes results to ensure all facets of data collection and interpretation meet client specifications.
- Recommend course of action or appropriate interpretation(s).
- Conduct research to determine appropriate approach and methodology for analyses.
- Prepare 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.
- Develop rules, benchmarks, etc. for the analysis and interpretation of model data.
- Clearly communicate rationale for analyses and outcomes to internal team, client and regulatory agencies, orally and in writing.
Requirements: Veteran Military
- US Veteran, National Guardsman, Reservist or Military Spouse.
- Master’s degree in statistics or mathematics (PhD preferred)
- 8+ in statistical analysis, with 3 years in biotechnology/pharmaceutical field, validation work
- Vaccine experience preferred; focused on biostats as primary career, not scientist with working knowledge
- Experience working with company used databases, statistical software packages and operating systems
- Experience with metrics tools and processes, statistical, data-collection and test development procedures; able to develop and resolve more complex issues. Prior experience managing subcontractors preferred.
- High skill level with SAS software, plus traditional and Bayesian statistical methods
- Ability to describe statistical approaches and analyses clearly to non-statisticians and clients
- Leadership skills to guide and mentor work of less experienced personnel