Pre-clinical and Clinical Biostatistician

Key Role:

Provide consulting services focused on development, qualification, and validation of pre-clinical and clinical assays and animal studies, diagnostic assays and tools, as well as clinical studies. Support the analytical planning and execution of health and healthcare data for government agencies including experimental and clinical trial designs, sample size, statistical analysis and interpretation of results. Maintain responsibility for analysis design, use of common preclinical and clinical data standards, Clinical Data Interchange Standards Consortium (CDISC) or Standard for Exchange of Nonclinical Data (SEND), quality control via appropriate application of statistical theory, modeling, including parametric and non-parametric for interpretation of results, and objective development for descriptive statistics to refine hypothesis. Perform clear and concise report writing, display oral expertise, use of visuals, simulations and other illustrative techniques, and present to satisfying client needs for highly visible government agencies. Assist with monitoring and assessing data integrity and accuracy using commonly accepted reliability and validity assurance practices appropriate for quantitative and qualitative data. Stay current with ongoing developments in statistical methods applications in the pharmaceutical industry, and assist with developing and defining frameworks for decision-making to guide and inform future study design choices.

Basic Qualifications:

  • 5 years of experience in the biopharmaceutical industry with extensive experience in non-clinical (animal) studies and assay validation
  • Experience in working with Standard for Exchange of Nonclinical Data (SEND) or Clinical Data Interchange Standards Consortium (CDISC) data standards
  • Experience with experimental design to meet Food and Drug Administration (FDA) regulation and International Council for Harmonisation (ICH) guidelines
  • Experience with a variety of statistical procedures and experimental design, statistical design of experiments, linear and non-linear models, adaptive trial design and Bayesian statistics, categorical data, and survival analysis
  • Ability to be flexible and organized, prioritize and multitask, and thrive with asking questions
  • Ability to obtain a security clearance
  • MS or MA degree in Statistics or Mathematics

Additional Qualifications:

  • Experience with Clinical Trial design and statistical analysis
  • Experience with working in team environments where not all members are professionally trained in statistical and quantitative studies
  • Experience with data mining and statistical modeling, including descriptive statistics, traditional modeling, and interpretation
  • Experience with data manipulation using statistical software
  • Experience with using SAS, including macros, arrays, and soft-coding at an intermediary level
  • Experience in working with R, including package use, program creation, and data exportation
  • Experience with analyzing large-scale data sets
  • Experience with program documentation and code commenting
  • Experience with data visualizations for broad audiences
  • Ability to work independently and as a member of a team
  • Ability to pay strict attention to detail
  • Possession of excellent data gathering, analytical, and problem-solving skills
  • Possession of excellent oral and written communication skills
  • Active Public Trust clearance
  • Ph.D. degree in Statistics or Mathematics


Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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