CMC Biostatistician: Analytical Method & Validation Lead

Orca Bio; Menlo Park (CA); On-site; USD 100,000 - 160,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k) plan

Parental leave

Subsidized daily lunches and snacks

Job summary

Orca Bio is hiring a Statistician to lead statistical analyses across analytical method development, validation, and product characterization for next-generation cell therapies.

You will partner with Analytical Development, Process Development, and Validation teams to design studies, handle non-normal data, and translate results into regulatory-defensible conclusions for decision-making across the product lifecycle.

Qualifications

• Advanced degree in statistics or related quantitative field.
• Experience applying statistics in biotech/pharma CMC/analytical development.
• Experience with comparability, specification setting, and non-normal data handling.

Responsibilities

• Design and execute comparability assessments using advanced statistics.
• Develop and apply tolerance interval methodologies.
• Perform Bland-Altman and method comparison analyses.
• Support analytical method validation with robust statistics.
• Prepare statistical sections for regulatory submissions.
• Develop reusable statistical templates and code (R/SAS/JMP/Python).
• Communicate statistical concepts clearly to non-statistical stakeholders.

Skills

JMP

R

SAS

Minitab

Python

Education

PhD in Statistics

MS in Biostatistics

BS in Statistics

Tools

JMP

R

SAS

Minitab

Python

Job description

Orca Bio is hiring a Statistician to lead statistical analyses across analytical method development, validation, and product characterization for next-generation cell therapies.

You will partner with Analytical Development, Process Development, and Validation teams to design studies, handle non-normal data, and translate results into regulatory-defensible conclusions for decision-making across the product lifecycle.