Sr. Statistician

This role supports analytical and scientific teams by providing advanced statistical expertise for method development, validation, and experimental design. Working closely with scientists, this position ensures robust analytical protocols, clear statistical documentation, and high-quality data interpretation to support regulatory readiness. The role requires strong technical depth in statistics, hands-on experience with analytical applications, and the ability to communicate complex findings to diverse stakeholders. This is an onsite/hybrid position based in Rahway, NJ.

Responsibilities

• Collaborate with scientists to design experimental protocols and establish acceptance criteria.
• Perform statistical analyses to support analytical method qualification and validation.
• Write technical memos and reports summarizing statistical results.
• Support scientists in evaluating protocol deviations and addressing investigation issues.
• Apply statistical methodologies such as DOE to improve assay robustness and performance.
• Coordinate with the Quality Audit team to finalize statistical reports for BLA readiness.
• Develop statistical software code to streamline or automate routine analyses (preferred).
• Present statistical findings and recommendations to management and cross-functional teams (preferred).

Education

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years of relevant work experience
• OR
• MS in Statistics/Applied Statistics with a minimum of 6 years of relevant work experience
• Note: Candidates with only a BS/BA will not be considered.

Experience

• Proficiency in SAS, R, and JMP.
• Proven experience in analytical method qualification and validation, including protocol development and statistical analysis.
• Experience designing experiments for analytical applications, including assay robustness and validation.
• Experience in predictive stability analysis.
• Preferred: mixed-effect modeling, Bayesian analysis, and creating automated statistical code.
• Preferred: strong presentation skills for communicating statistical results to management.

Additional Information

• Onsite/Hybrid only.
• Hybrid location: Rahway, NJ.
• Strong collaboration and documentation skills are essential.