CMC Statistician (Biologics) – Regulatory Analytics

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

Life and disability coverage

Parental leave benefits

On-site meals

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 collaborate with Analytical Development, Process Development, and Validation teams to design studies, analyze complex data, and translate results into regulatory-defensible conclusions that inform process and product decisions across the lifecycle.

Qualifications

• BS/MS/PhD in Statistics, Biostatistics, Applied Mathematics, or related quantitative field
• 6+ years (BS), 3+ years (MS), or 1+ years (PhD) of industry experience applying statistics in biotech/pharma
• Experience with comparability assessment methodologies for biologics or small molecules
• Experience supporting analytical method validation including non-normal data and robust statistics
• Proficiency in JMP, R, SAS, or Python
• Knowledge of ICH Q2(R2), Q14, FDA and EMA guidance related to analytical procedures and comparability
• Strong communication skills and ability to explain statistical concepts to non-statistical audiences
• Attention to detail and ability to manage multiple projects in a regulated environment

Responsibilities

• Design and execute comparability assessments for process changes, site transfers, scale-up/scale-down activities, and reference standard qualification
• Develop and apply tolerance interval methodologies to establish specifications and control limits
• Conduct Bland-Altman analysis and method-comparison evaluations across platforms and laboratories
• Provide statistical support for analytical method validation/verification including transformation strategies for non-normal data
• Author and review statistical sections of validation protocols and regulatory submissions
• Develop and maintain statistical code/templates (R, SAS, JMP, Python)
• Collaborate with cross-functional teams to design fit-for-purpose DOE experiments and sampling plans

Skills

Statistical analysis

Regulatory communication

Non-normal data handling

Bootstrap methods

Data interpretation

Education

Statistics/Biostatistics degree

Tools

JMP

R

SAS

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 collaborate with Analytical Development, Process Development, and Validation teams to design studies, analyze complex data, and translate results into regulatory-defensible conclusions that inform process and product decisions across the lifecycle.