Statistician, CMC (Chemistry, Manufacturing, and Controls)

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

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Position Summary: We are seeking a skilled Statistician to join our CMC organization and provide statistical leadership across analytical method development, validation, comparability, and product characterizationactivities. The successful candidate will partner closely with Analytical Development, ProcessDevelopment, and Validation teams to design studies, analyze complex data (including non-normaldistributions common in biologics assays), and translate results into clear, regulatory-defensibleconclusions that support process and product decisions across the product lifecycle.In this role, you will provide hands-on statistical expertise across the full product lifecycle, from earlyanalytical method development through commercial manufacturing, ensuring compliance with ICH, FDA,and EMA guidance.

Essential Duties & Key Responsibilities

• Design and execute comparability assessments for process changes, site transfers, scale-up/scale-down activities, and reference standard qualification, utilizing equivalence testing,quality range methods, and mixed-effects models to establish pre-specified acceptance criteria.
• Develop and apply tolerance interval methodologies (parametric, non-parametric, anddistribution-free approaches) to establish specifications, in-process control limits, and shelf-life/stability ranges across the product lifecycle.
• Conduct Bland-Altman analysis and method-agreement/method-transfer evaluations to assessbias, limits of agreement, and comparability between analytical platforms, instruments, andlaboratories.
• Provide statistical support for analytical method validation and verification, including accuracy,precision, linearity, range, and robustness studies, with particular expertise in handling non-normal and skewed data through transformation strategies and non-parametric methods.
• Author and review statistical sections of validation protocols, reports, and summary statisticspackages suitable for regulatory submissions (BLA/MAA/NDA, CTD Module 3) and responses tohealth authority queries.
• Develop, validate, and maintain statistical code and templates (R, SAS, JMP, Python) to ensureconsistency, traceability, and reproducibility of analyses; stay current with ICH, FDA, and EMAguidance on comparability, analytical procedures, and statistical methods.
• Collaborate with Analytical Development, Process Development, QC, and Regulatory Affairs todesign fit-for-purpose experimental designs (DOE), sampling plans, and risk assessments whilecommunicating statistical concepts clearly to non-specialist stakeholders.

Experience & Education

• B.S., M.S., or Ph.D. in Statistics, Biostatistics, Applied Mathematics, or a related quantitative field(or equivalent experience).
• 6+ years (B.S.), 3+ years (M.S.), or 1+ years (Ph.D.) of relevant industry experience applyingstatistics within a CMC, analytical development, or QC environment in biotech/pharma.
• Demonstrated hands-on experience with comparability assessment methodologies for biologicsor small molecules, tolerance interval construction (parametric and non-parametric), and Bland-Altman/method-comparison techniques.
• Demonstrated experience providing statistical support for analytical method validation,including strategies for non-normal/non-Gaussian data, robust statistics, and bootstrappingmethods.
• Proficiency in a statistical programming language (JMP preferred; R, SAS, Minitab, or Python alsorelevant).
• Working knowledge of relevant ICH Q2(R2), Q14, FDA, and EMA guidance related to analyticalprocedures, comparability, and specification setting.
• Strong written and verbal communication skills with ability to explain statistical reasoning tocross-functional, non-statistical audiences.
• Excellent attention to detail and ability to manage multiple concurrent projects in a fast-paced,highly regulated environment.

$100,000 - $160,000 a year

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market.

Full-time employment positions will also be eligible to receive:

• pre-IPO equity and annual bonus
• competitive medical, dental, and vision benefits
• PTO
• 401(k) plan
• life and accidental death and disability coverage
• parental leave benefits
• subsidized daily lunches and snacks at our on-site locations

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask "why not" and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.