Statistician (Scientist I)

About the role

The Scientist I (Statistics) supports the application of statistical methods to bioanalytical assay development, qualification, and validation activities within the Quality Control and Analytical Development functions. This role applies established statistical approaches to ensure data integrity, regulatory compliance, and accurate interpretation of analytical results. The Scientist I collaborates cross-functionally to support experimental design, data analysis, and documentation, contributing to the advancement of gene therapy programs.

What You'll Do

• Apply established statistical methods to support development, qualification, and validation of bioanalytical methods (e.g., potency assays, ddPCR workflows)
• Perform statistical analyses for assay validation, including linearity, accuracy, precision, and detection limits
• Support stability studies through trend analysis, control charting, and regression modeling
• Aid in data review, interpretation, and troubleshooting for assay development and optimization activities
• Contribute to statistical analysis plans (SAPs), validation protocols, technical reports, and regulatory documentation
• Collaborate with cross-functional teams (QC, Analytical Development, Process Development, Regulatory)
• Support investigations, deviations, and root cause analyses with statistical input
• Aid in developing and maintaining data trending and reporting tools
• Ensure compliance with regulatory requirements (e.g., ICH, USP, FDA)
• Communicate statistical findings clearly to stakeholders

What You'll Bring

• Ph.D. in Statistics or related field (or Master’s with relevant experience)
• 1–3 years of relevant experience in a biopharmaceutical, biotechnology, or analytical laboratory setting
• Experience with statistical software (JMP, SAS, R, Python)
• Strong analytical and problem-solving skills
• Effective written and verbal communication skills
• Ability to work independently within defined frameworks and collaborate across teams

Preferred Skills

• Familiarity with nucleic acid-based assays (e.g., ddPCR, qPCR)
• Experience with protein or cell-based assays (e.g., ELISA, flow cytometry)
• Experience in GxP-regulated environments
• Exposure to assay validation and stability studies