Statistician - CMC, Chemistry, Manufacturing, And Controls
$100k - $160k/yr+ Pre-IPO equity + Annual bonus
Senior
Bachelor's, Master's, PhD
Menlo Park, CA, USA
In Person
Biology & BiotechQuantitative Biology & Biostatistics
About the job
Requirements
- A B.S., M.S., or Ph.D. in Statistics, Biostatistics, Applied Mathematics, or a related quantitative field, or equivalent experience.
- At least 6 years of relevant industry experience with a B.S., 3 years with an M.S., or 1 year with a Ph.D., applying statistics within a CMC, analytical development, or quality control environment in biotechnology or pharmaceutical industries.
- Hands-on experience with comparability assessment methodologies for biologics or small molecules, tolerance interval construction using parametric and non-parametric methods, and Bland-Altman or method-comparison techniques.
- Experience providing statistical support for analytical method validation, including strategies for non-normal or non-Gaussian data, robust statistics, and bootstrapping methods.
- Proficiency in a statistical programming language, with JMP preferred and R, SAS, Minitab, or Python also relevant.
- Working knowledge of ICH Q2(R2), Q14, FDA, and EMA guidance related to analytical procedures, comparability, and specification setting.
- Strong written and verbal communication skills, with the ability to explain statistical reasoning to cross-functional, non-statistical audiences.
- Attention to detail and the ability to manage multiple concurrent projects in a fast-paced, highly regulated environment.
Responsibilities
- Design and execute comparability assessments for process changes, site transfers, scale-up and scale-down activities, and reference standard qualification, using equivalence testing, quality range methods, and mixed-effects models to establish pre-specified acceptance criteria.
- Develop and apply parametric, non-parametric, and distribution-free tolerance interval methodologies to establish specifications, in-process control limits, and shelf-life or stability ranges across the product lifecycle.
- Conduct Bland-Altman analysis and method-agreement or method-transfer evaluations to assess bias, limits of agreement, and comparability between analytical platforms, instruments, and laboratories.
- Provide statistical support for analytical method validation and verification, including accuracy, precision, linearity, range, and robustness studies, with expertise in handling non-normal and skewed data through transformation strategies and non-parametric methods.
- Author and review statistical sections of validation protocols, reports, and summary statistics packages suitable for regulatory submissions, including BLA, MAA, NDA, and CTD Module 3 submissions, and responses to health authority queries.
- Develop, validate, and maintain statistical code and templates in R, SAS, JMP, and Python to ensure consistency, traceability, and reproducibility of analyses.
- Stay current with ICH, FDA, and EMA guidance on comparability, analytical procedures, and statistical methods.
- Collaborate with Analytical Development, Process Development, Quality Control, and Regulatory Affairs to design fit-for-purpose experimental designs, sampling plans, and risk assessments.
- Communicate statistical concepts clearly to non-specialist stakeholders.
About the company
Orca Bio develops and commercializes cell therapies to improve outcomes for patients. It works by researching, developing, and producing therapies that use the body’s own cells to treat diseases, with products sold to healthcare providers who administer them to patients. The company aims to enhance the safety and effectiveness of cell therapies, making treatments more reliable for conditions that lack good options. Orca Bio differentiates itself through its focus on delivering safer, more effective therapies and by fostering a strong team culture with active stakeholder communication, including a regularly updated newsroom. Overall, its goal is to expand access to improved cell therapies and become a leading player in the cell therapy market.
Company Size
201-500
Company Stage
Series F
Total Funding
$542M
Headquarters
North Fair Oaks, California
Founded
2016
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Simplify's Take
What believers are saying
- FDA approval on June 30, 2026 validates Orca Bio's platform and pipeline.
- The company raised $250 million in December 2025, funding launch and expansion.
- Princeton capacity and Sacramento hiring support commercialization and faster nationwide patient delivery.
What critics are saying
- TREGZI costs $428,000, forcing transplant centers and payers into tough coverage fights.
- Complex donor-specific manufacturing can bottleneck supply, delaying launches beyond the planned 25 centers.
- Any post-marketing safety signal or FDA CMC issue would cripple Orca Bio's only commercial product.
What makes Orca Bio unique
- Orca Bio's TREGZI won FDA approval on June 30, 2026, first precision cell therapy.
- Its donor-derived regulatory T-cell design directly reduces chronic GVHD after transplant.
- Princeton and Sacramento manufacturing create a bicoastal vein-to-vein network for personalized production.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Unlimited Paid Time Off
- 401(k) Retirement Plan
- Parental Leave