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Forge Biologics is seeking a Statistician (Scientist I) to support statistical applications in bioanalytical assay development, qualification, and validation within Quality Control and Analytical Development. Based in Columbus, Ohio at The Hearth—a 200,000-square-foot cGMP manufacturing facility—you will apply established statistical methods to ensure data integrity, regulatory compliance, and accurate interpretation of analytical results in gene therapy programs.
Key responsibilities include: applying statistical methods to bioanalytical assay development (potency assays, ddPCR workflows); performing statistical analyses for assay validation (linearity, accuracy, precision, detection limits); supporting stability studies through trend analysis, control charting, and regression modeling; assisting in data review, interpretation, and troubleshooting; contributing to statistical analysis plans (SAPs), validation protocols, technical reports, and regulatory documentation; collaborating cross-functionally with QC, Analytical Development, Process Development, and Regulatory teams; supporting investigations and root cause analyses; developing and maintaining data trending and reporting tools; ensuring FDA/ICH/USP compliance; and communicating statistical findings to stakeholders.
Required qualifications: Ph.D. in Statistics or related field (or Master's with relevant experience); 1–3 years in biopharmaceutical, biotechnology, or analytical laboratory settings; proficiency with statistical software (JMP, SAS, R, Python); strong analytical and problem-solving skills; effective written and verbal communication; ability to work independently and collaborate across teams.
Preferred: familiarity with nucleic acid assays (ddPCR, qPCR), protein/cell-based assays (ELISA, flow cytometry), GxP-regulated environments, and assay validation/stability study experience.
Forge Biologics operates with a culture centered on H.O.P.E.: hardworking, open, purpose-driven, and engaged. The company is committed to employee growth through mentorship, hands-on learning, and advancement opportunities. The role involves working in a temperature-controlled laboratory/office environment with regular standing, hand manipulation, and laboratory equipment use; may involve lifting up to 25 pounds and PPE requirements.
