# Statistician, CMC (Chemistry, Manufacturing, and Controls) at Orca Bio

- Company: Orca Bio
- What the company does: Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
- Company website: https://orcabio.com/
- Type: Startups
- Level: Mid level
- Location: Menlo Park, CA
- Work setup: On-site
- Pay: $100K to $160K base salary per year (USD)
- Posted: 2026-08-04
- Apply by: 2026-10-08
- Apply: https://jobs.lever.co/orcabiosystems/8673dade-f19b-4fe2-bc7b-59dfc3e48e90
- Page: https://www.1752.vc/careers/jobs/orca-bio-statistician-cmc-chemistry-manufacturing-and-controls/

## 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

Tags: Chemistry, Manufacturing & Controls