Statistician

Responsibilities

• Apply statistical methods to support development, qualification, and validation of bioanalytical methods
• Perform statistical analyses for assay validation including linearity, accuracy, and precision
• Support stability studies through trend analysis, control charting, and regression modeling
• Contribute to statistical analysis plans, validation protocols, and technical reports
• Collaborate with cross-functional teams including QC, Analytical Development, and Regulatory
• Support investigations and root cause analyses with statistical input
• Ensure compliance with regulatory requirements such as ICH, USP, and FDA

Requirements

• Ph.D. in Statistics or related field, or Master’s with relevant experience
• 1–3 years of experience in biopharmaceutical, biotechnology, or analytical laboratory settings
• Proficiency with statistical software such as JMP, SAS, R, or Python
• Strong analytical and problem-solving skills
• Effective written and verbal communication skills

Preferred Qualifications

• Familiarity with nucleic acid-based assays like ddPCR or qPCR
• Experience with protein or cell-based assays such as ELISA or flow cytometry
• Experience working in GxP-regulated environments
• Exposure to assay validation and stability studies

Benefits

• Health, dental, and vision insurance starting day one
• 12 weeks of fully paid parental leave
• Annual bonus opportunities
• 401(k) with company match
• Onsite fitness facility
• Mental health counseling and financial planning services
• Fully stocked kitchen with free snacks and beverages

About the Company

Forge Biologics is dedicated to enabling access to life-changing gene therapies. Operating out of a state-of-the-art cGMP facility in Columbus, Ohio, the company partners with scientists and biotech innovators to bring advanced therapies from idea to reality.