CMC Statistician - Biotech Analytics Lead (Remote)

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

Benefits offered by this job

Meal benefits at on-site locations

On-site cafeterias

Job summary

Orca Bio is seeking a skilled Statistician to join our CMC organization, providing leadership across analytical method development, validation, comparability, and product characterization. You will design studies, analyze complex non-normal data, and translate results into regulatory-defensible conclusions supporting decisions across the product lifecycle.

You will develop statistical code (R, SAS, JMP, Python) and collaborate with Analytical Development, Process Development, QC, and Regulatory

Qualifications

• BS, MS, or PhD in Statistics, Biostatistics, Applied Mathematics, or related field.
• 6+ years (BS), 3+ years (MS), 1+ years (PhD) industry experience applying statistics in biotech/pharma.
• Hands-on experience with comparability methodologies for biologics or small molecules; tolerance interval methods; Bland-Altman/method-comparison techniques.
• Experience providing statistical support for analytical method validation including non-normal data, robust statistics, and bootstrapping.

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, in-process control limits, and shelf-life ranges.
• Conduct Bland-Altman and method-comparison evaluations to assess bias and agreement between platforms and laboratories.
• Provide statistical support for analytical method validation/verification including accuracy, precision, linearity, range, and robustness with non-normal data.
• Author and review statistical sections of validation protocols, reports, and regulatory submission packages (BLA/MAA/NDA, CTD Module 3).
• Develop, validate, and maintain statistical code and templates (R, SAS, JMP, Python); stay current with ICH, FDA, EMA guidance.

Skills

Statistical programming (R/SAS/Python)

DOE design

Non-normal data handling

Bland-Altman analysis

Education

Statistics/Biostatistics/Applied Mathematics degree

Tools

JMP

R

SAS

Python

Minitab

Job description

Orca Bio is seeking a skilled Statistician to join our CMC organization, providing leadership across analytical method development, validation, comparability, and product characterization. You will design studies, analyze complex non-normal data, and translate results into regulatory-defensible conclusions supporting decisions across the product lifecycle.

You will develop statistical code (R, SAS, JMP, Python) and collaborate with Analytical Development, Process Development, QC, and Regulatory