Biostatistician

Job Description

Duties and 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.

Education:

• BS in Statistics or Biostatistics + 5 years of experience.
• MS in Statistics or Biostatistics + 1 year of experience.
• 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.