Senior Statistician, CMC Biotech – Remote Options

Orcabiosystems; Edison (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, vision benefits

PTO

Job summary

Orca Bio is 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 and analyze complex data.

You will translate results into regulatory-defensible conclusions that support process and product decisions across the

Qualifications

• Advanced degree in statistics/biostatistics or related field plus industry experience.
• Experience with comparability assessment methodologies for biologics or small molecules.
• Experience supporting analytical method validation/verification in biotech/pharma.

Responsibilities

• Lead statistical analyses across analytical method development, validation, and comparability.
• Provide regulatory-defensible conclusions to support lifecycle decisions.
• Develop and maintain statistical code/templates (R, SAS, JMP, Python).
• Collaborate with cross-functional teams to design DOE and sampling plans.
• Prepare statistical sections for regulatory submissions (BLA/MAA/NDA).
• Interpret non-normal data with robust or non-parametric methods.

Skills

Statistical analysis

Biostatistics

DOE

Regulatory submissions

R

SAS

Python

JMP

Bland-Altman

Comparability

Education

MS in Statistics/Biostatistics

PhD in a related field

Tools

R

SAS

JMP

Python

Job description

Orca Bio is 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 and analyze complex data.

You will translate results into regulatory-defensible conclusions that support process and product decisions across the