Statistician

Position:
Statistician, CMC (Chemistry, Manufacturing, and Controls)

Company:
Orca Bio

Compensation:
$100,000 - $160,000 a year

Location:
United States, Menlo Park, CA

Employment type:
Regular, Full-Time Employee

Work Arrangement:
On-site

Short Summary:
Orca Bio is seeking a skilled Statistician to provide statistical leadership across analytical method development, validation, comparability, and product characterization activities, ensuring compliance with ICH, FDA, and EMA guidance.

Responsibilities:
- Design and execute comparability assessments for process changes, site transfers, and reference standard qualification.
- Develop and apply tolerance interval methodologies for specifications and control limits.
- Conduct Bland-Altman analysis and method-agreement evaluations.
- Provide statistical support for analytical method validation and verification.
- Author and review statistical sections of validation protocols and reports for regulatory submissions.
- Develop, validate, and maintain statistical code and templates.
- Collaborate with various teams to design experimental designs and communicate statistical concepts.

Requirement:
- B.S., M.S., or Ph.D. in Statistics, Biostatistics, Applied Mathematics, or a related field.
- 6+ years (B.S.), 3+ years (M.S.), or 1+ years (Ph.D.) of relevant industry experience.
- Hands-on experience with comparability assessment methodologies and statistical support for analytical method validation.
- Proficiency in a statistical programming language (JMP preferred; R, SAS, Minitab, or Python also relevant).
- Strong written and verbal communication skills.
- Excellent attention to detail and ability to manage multiple projects.

Benefits:
- Eligible for pre-IPO equity and annual bonus.
- Competitive medical, dental, and vision benefits.
- PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
- Subsidized daily lunches and snacks at on-site locations.