Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
About the role
Position Summary: We are seeking a skilled Statistician to join our CMC organization and provide statistical leadership across analytical method development, validation, comparability, and product characterization activities.
What they're looking for
- B.S., M.S., or Ph.D. in Statistics, Biostatistics, Applied Mathematics, or a related quantitative field (or equivalent experience)
- 6+ years (B.S.), 3+ years (M.S.), or 1+ years (Ph.D.) of relevant industry experience applying statistics within a CMC, analytical development, or QC environment in biotech/pharma
- Demonstrated experience providing statistical support for analytical method validation, including strategies for non-normal/non-Gaussian data, robust statistics, and bootstrapping methods
- Proficiency in a statistical programming language (JMP preferred, R, SAS, Minitab, or Python also relevant)
- Working knowledge of relevant ICH Q2(R2), Q14, FDA, and EMA guidance related to analytical procedures, comparability, and specification setting
- Strong written and verbal communication skills with ability to explain statistical reasoning to cross-functional, non-statistical audiences
More about this role
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary: We are seeking a skilled Statistician to join our CMC organization and provide statistical leadership across analytical method development, validation, comparability, and product characterization activities. The successful candidate will partner closely with Analytical Development, Process Development, and Validation teams to design studies, analyze complex data (including non-normal distributions common in biologics assays), and translate results into clear, regulatory-defensible conclusions that support process and...
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