BioSpace · 2 days ago

Safety Statistician, Senior Manager

Washington, DC

Full-time

Hybrid

Senior Level

4+ years exp

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Comp. & Benefits

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Responsibilities

Provide statistical expertise to Centralized Statistical Monitoring and Quality Tolerance Limit projects

Plan and execute statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).

Provide statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.

Oversee statistical work performed by study statisticians.

Qualification

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Doctorate degreeMasters degreeAssociates degreeStatistical AnalysisClinical TrialsBayesian MethodologyData VisualizationR/ShinyProblem-SolvingEffective CommunicationCross-Cultural Collaboration

Required

Doctorate degree and 2 years of experience OR

Masters degree and 4 years of experience OR

Bachelors degree and 6 years of experience OR

Associates degree and 10 years of experience OR

High school diploma / GED and 12 years of experience

Preferred

Technically strong with hands-on experience of various design and statistical analysis

Clinical trial experience

Any safety assessment experience and/or experience of application of Bayesian methodology in a clinical trials environment is a plus

Experience working effectively in a globally dispersed team environment with cross-cultural partners

Proficiency in developing or supervising the development of data visualization tools and data analysis applications using e.g. R/Shiny is highly desirable