Job Description

Public Trust: None

Requisition Type: Regular

Your Impact

Own your opportunity to work alongside federal civilian agencies. Make an impact by providing services that help the government ensure the well being of U.S. citizens.

Job Description

GDIT/ Dynport Vaccine Company (DVC) is hiring a Biostatistician to support a Biological testing program. The Biostatistician will provide statistical analyses of assays to evaluate assay performance and product quality.

(estimation of hours will be ~ 3-6 per year)

HOW YOU WILL MAKE AN IMPACT:

• Responsible for providing technical expertise to the DVC product teams, subcontractors and clients for statistical analysis.
• Responsible for statistical analysis, including analyzing correlates of immunity for vaccines and product efficacy.
• Responsible for providing input to determine the population size required to meet confidence intervals of required studies or trials.
• Responsible for preparing conclusions and predictions based on data summaries and advising clients on benefits and limitations of statistical processes adopted in data collection and analysis to ensure that clients use information to make informed decisions.
• Responsible for determining the appropriate approach and methodology for analyses.
• Responsible for writing/reviewing/approving documents related to statistical analysis and results.
• Responsible for reviewing work performed by statistical subcontractors.
• Responsible for supporting multiple functional areas, including product and assay development, manufacturing, nonclinical and clinical areas.
• Responsible for participating in interactions with regulatory agencies, as required.

WHAT YOU’LL NEED TO SUCCEED:

• Master’s degree in statistics, mathematics or related field with 7+ of years experience in analysis of biostatistics OR PhD degree in statistics, mathematics or related field with 5+ years of experience in analysis of biostatistics. 
• 3+ years of experience in the biotechnology/pharmaceutical industry. 
• Ability to describe statistical approaches clearly to non-statisticians and clients.
• Experience with the analysis and evaluation of data sets in order to apply statistical methodology in the appropriate software packages required for FDA submissions.
• Experience with SAS and JMP software and both traditional and Bayesian statistical methods.
• Experience with metrics tools and processes.
• Experience with statistical, data-collection and test development procedures.
• Experience with analysis of data from Design of Experiments.

SKILLS & ATTRIBUTES FOR SUCCESS:

• Ability to work independently or as part of an integrated project team.
• Possess strong analytical and problem solving skills.

GDIT IS YOUR PLACE:

• 401K with company match
• Comprehensive health and wellness packages
• Internal mobility team dedicated to helping you own your career
• Professional growth opportunities including paid education and certifications
• Cutting-edge technology you can learn from

Work Requirements

Years of Experience

7 + years of related experience

* may vary based on technical training, certification(s), or degree

Certification

Travel Required

None

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