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