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Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies for blood cancer patients. The company is redefining the transplant process with purified, high-precision cell therapies designed to improve survival rates and reduce risks like graft-versus-host disease.
You will join the CMC (Chemistry, Manufacturing, and Controls) organization as a Statistician, providing statistical leadership across analytical method development, validation, comparability, and product characterization activities. This is a hands-on role spanning the full product lifecycle, from early analytical method development through commercial manufacturing.
Key responsibilities include:
- Partner with Analytical Development, Process Development, and Validation teams to design rigorous statistical studies
- Analyze complex datasets, including non-normal distributions common in biologics assays
- Translate statistical findings into clear, regulatory-defensible conclusions that inform process and product decisions
- Ensure compliance with ICH, FDA, and EMA guidance throughout analytical and manufacturing activities
- Provide statistical expertise in method validation, comparability studies, and product characterization
- Support decision-making across the product lifecycle with data-driven insights
This role requires deep statistical knowledge in the context of regulated biologics manufacturing, strong communication skills to translate technical findings for cross-functional teams, and experience with the regulatory landscape governing cell and gene therapies. You will work closely with development and manufacturing teams to ensure statistical rigor in all CMC activities.
