Method Qualification​/Biostatistician; GForce​/CuriBio

Seattle, United States | Posted on 10/27/2026

Pioneer GMP Consulting is a specialized life sciences consultancy focused on delivering high-impact GMP compliance, validation, and quality system solutions to biopharmaceutical clients. We support startups, CDMOs, and global manufacturers across the product lifecycle, from clinical-stage development to commercial readiness.

Schedule: Approximately 10-20 Hours per Week

Location: U.S.

-Based;
Approximately 80% Remote and 20% Onsite in Seattle, Washington

Duration: Approximately Two Months

Start Date: TBD

Employment Structure: W2 Hourly or Independent Consulting Arrangement, Based On Final Engagement Terms

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.

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

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…