Source description
About the role
Exact Shift - 8am-5pm, M-F, OT possible
Duration of assignment - 6months, possible extension.
This is a remote role
Responsibilities
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• Write and review statistical analysis plans for analytical and clinical validation studies.
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• Apply DOE principles, conduct statistical analyses, and clearly communicate interpretations.
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• Calculate clinical accuracy metrics (PPA, NPA, PPV, NPV) and deliver analyses to support regulatory filings.
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• Generate tables, listings, and figures aligned with study protocols.
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• Review and QC statistical outputs from peers, ensuring scientific integrity.
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• Write and validate SAS code and macros to support standardized workflows.
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• Collaborate in cross-functional study teams, contributing data-driven insights that influence key decisions.
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• Partner with colleagues across functions to advance innovative diagnostics.
Qualifications
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Education
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• BS in Statistics or Biostatistics + 5 years of experience, OR
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• MS in Statistics or Biostatistics + 1 year of experience, OR
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• PhD in Statistics or Biostatistics.
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• SAS programming certification is a plus.
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Experience
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• Proven experience as a statistician in IVD, medical devices, pharmaceutical, or life sciences settings.
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• Strong SAS (BASE, STAT, MACRO, GRAPH) programming Skills.
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• Experience analyzing complex data from multiple sources and familiarity with CLSI standards.
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• Knowledge of Next-Generation Sequencing (NGS) is a plus.
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Knowledge, Skills & Abilities
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• Solid understanding of statistical theory, experimental design, and clinical trial methodologies.
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• Proficiency with linear and non-linear modeling, mixed models, categorical and nonparametric methods, bootstrapping, multiple imputations, and sample size calculations.
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• Ability to manage multiple projects in a fast-paced environment.
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• Skill in translating scientific questions into practical, data-analytic solutions.
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• Excellent written and verbal communication skills — able to simplify complex ideas and build strong partnerships.
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• Flexibility to work across multiple time zones when needed.
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