Statistician/Biostatistician

Job Description Looking for a Statistician/Biostatistician to support analytical and clinical studies for diagnostic products. This role focuses on writing statistical analysis plans, analyzing clinical and validation data, and supporting regulatory submissions. You will use SAS to run analyses, create tables and figures, and ensure accuracy and quality of statistical outputs.

• 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements

• 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.
• 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.
• 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.
• SAS programming certification.
• Knowledge of Next-Generation Sequencing (NGS).