Potency Method Qualification Consultant – Biostatistics
About the Opportunity
Pioneer GMP Consulting is seeking an experienced Potency Method Qualification Consultant with strong biostatistics expertise to support an innovative life sciences organization preparing a method qualification plan for submission to the FDA.
The consultant will lead the development of a scientifically sound, statistically defensible Method Qualification Plan supporting an FDA Innovative Science and Technology Approaches for New Drugs—or iSTAND—application. The work will require close collaboration with scientific, analytical, regulatory, and executive stakeholders to translate the proposed method and its intended use into an executable qualification strategy.
This is a fractional consulting engagement expected to require approximately 10–20 hours per week for about two months. Most planning, authoring, statistical analysis, and regulatory support may be completed remotely. Approximately 20% onsite support in Seattle is anticipated for qualification execution or oversight.
The final schedule, start date, onsite dates, employment structure, and compensation will be confirmed as the project scope develops.
What You’ll Do
Lead the development of a Method Qualification Plan supporting an FDA iSTAND application
Develop a statistically appropriate qualification strategy based on the method’s intended use, scientific principles, and regulatory expectations
Define qualification parameters, study design, sample requirements, replicate strategy, acceptance criteria, and statistical-analysis methods
Address relevant performance characteristics, such as precision, accuracy, linearity, range, specificity, robustness, variability, and reproducibility, as applicable to the method
Determine appropriate statistical methods for evaluating method performance and qualification results
Evaluate sample-size considerations and ensure the proposed design produces scientifically meaningful and defensible conclusions
Translate complex scientific and statistical concepts into clear, executable qualification requirements
Author or substantially contribute to the Method Qualification Plan and supporting technical documentation
Review available method-development data, protocols, procedures, and supporting scientific information
Identify gaps, assumptions, risks, or additional information needed before qualification begins
Partner with client scientists, laboratory personnel, regulatory stakeholders, and leadership to refine the qualification approach
Provide statistical and technical support in response to FDA questions, comments, or concerns regarding the proposed approach
Revise the qualification strategy or supporting documentation based on regulatory feedback
After plan acceptance, execute qualification activities onsite in Seattle or oversee client personnel performing the work
Monitor execution against the approved plan and help resolve discrepancies, unexpected results, or protocol questions
Review qualification data for completeness, accuracy, and adherence to the approved statistical approach
Support interpretation of results and preparation of qualification conclusions or final reporting
Communicate progress, risks, decisions, data needs, and recommended actions clearly
Maintain complete, accurate, traceable, and submission-ready documentation
Represent Pioneer with professionalism, scientific credibility, sound judgment, and accountability
Required Qualifications
Advanced degree in biostatistics, statistics, analytical chemistry, biochemistry, pharmaceutical sciences, biomedical engineering, or a related scientific discipline
Direct experience developing or qualifying analytical, biological, potency, or other quantitative methods within a regulated life sciences environment
Strong biostatistics experience applied to analytical-method development, qualification, validation, or comparability studies
Experience designing statistically defensible studies, including sample-size, replicate, variability, acceptance-criteria, and data-analysis considerations
Experience authoring method qualification plans, protocols, technical reports, statistical-analysis plans, or comparable regulated documentation
Working knowledge of method-performance characteristics and risk-based qualification principles
Experience interpreting complex scientific data and translating results into defensible conclusions
Experience supporting FDA submissions, regulatory interactions, or responses to regulatory questions
Strong scientific and technical-writing skills
Ability to communicate statistical concepts clearly to scientific and non-statistical stakeholders
Ability to work independently and provide senior-level technical guidance with limited oversight
Ability to manage a focused, time-sensitive consulting scope requiring approximately 10–20 hours per week
Ability to travel to Seattle for approximately 20% of the engagement, including onsite execution or oversight activities
Ability to collaborate effectively in a fractional, client-facing consulting environment
What Will Set You Apart
Direct experience supporting an FDA iSTAND application
Experience developing qualification strategies for novel or emerging scientific methods
Experience with potency methods, biological assays, complex in vitro models, or other variable biological systems
Experience leading both the statistical design and practical execution of a method qualification
Experience responding directly to FDA statistical or methodological questions
Experience working with emerging biotechnology companies or multidisciplinary scientific teams
Experience identifying practical solutions when method-development data are limited or variability is high
Prior consulting or fractional advisory experience
Ability to enter an evolving project, ask focused questions, and establish a clear technical path quickly
Availability to begin promptly and support the project through regulatory feedback and qualification execution
What Success Looks Like
You will be successful in this engagement when:
The qualification strategy is scientifically sound, statistically defensible, and aligned with the method’s intended use
The Method Qualification Plan clearly defines how performance will be evaluated and how acceptance decisions will be made
Statistical assumptions, risks, and limitations are identified and addressed appropriately
Client stakeholders understand the proposed approach and can execute it consistently
FDA questions or concerns receive clear, well-supported responses
Onsite execution follows the accepted plan and produces complete, reliable, and traceable data
Unexpected results or execution issues are evaluated promptly and objectively
Qualification conclusions are supported by the approved statistical approach and available evidence
Deliverables are completed within the engagement’s compressed timeline
The client views you as technically credible, responsive, collaborative, and solutions-oriented
Know Before You Apply
This is a short-term, part-time consulting engagement expected to last approximately two months.
The anticipated workload is approximately 10–20 hours per week and may vary based on project and FDA-response needs.
Approximately 80% of the work is expected to be remote.
Approximately 20% onsite support in Seattle is anticipated for qualification execution or oversight.
Onsite dates will be coordinated based on project readiness and the accepted qualification plan.
This is a hands-on technical role requiring direct authorship, statistical strategy, and execution support—not a general advisory assignment.
The scope and timeline may evolve based on FDA feedback, method readiness, and qualification results.
Please disclose any scheduling, travel, availability, employment-structure, or potential conflict-of-interest limitations during the recruiting process.
Compensation
Compensation Range: To Be Confirmed
Compensation will be determined based on technical expertise, employment or consulting structure, project requirements, and other job-related factors.
Travel reimbursement and related expenses may apply for approved onsite activities in accordance with the applicable engagement terms.
About Pioneer GMP Consulting
Pioneer GMP Consulting provides quality, compliance, validation, engineering, regulatory, technology, and operational support to pharmaceutical, biotechnology, and other life sciences organizations.
Our consultants work as embedded partners within client teams, applying practical experience, critical thinking, and sound scientific and regulatory judgment to solve complex problems and move important work forward.
Equal Opportunity Employer
Pioneer GMP Consulting is an Equal Opportunity Employer. We consider qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable federal, state, or local law.