Biostatistician / Pharmaceutical Product Development
110 Thomas Johnson Drive Frederick, MD
BroadStaff is thrilled to be working with our client, a multi-level division company supporting some of the most complex government, defense, and intelligence projects across the country through innovative solutions. They are seeking a Biostatistician to support the Pharmaceutical Product Development team for U.S. and international government agencies providing consulting services to biotechnology and pharmaceutical companies to protect soldiers and civilians against emerging diseases and possible bioterror threats. The position is an indefinite contract role with possibility for Full Time conversion based in the Fredrick, MD office.
In this role, the Biostatistician will have experience in analyzing pharmaceutical product development and manufacturing, nonclinical and clinical development to lead the statistical analysis of vaccine development for a biodefense program. The successful candidate becomes an important champion for this extraordinary company culture and will have the opportunity to make substantial contributions toward the development of vaccines and therapeutics that will protect civilians and dedicated Armed Forces men and women
- Leads the statistical analysis of 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.
- Master' s degree in statistics or mathematics, with a PhD in statistics or mathematics preferred
- Eight or more years of experience in statistical analysis, with at least three years in the biotechnology/pharmaceutical field, including validation work.
- 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
- 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