Statistical Consultant

United Pharma; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

United Pharma seeks an experienced Statistical Consultant to guide statistical methodologies for vaccine development and regulatory submissions across global programs. You will partner with CMCS S and AST teams to shape analyses for method transfer, forced degradation, and comparability studies.

The role emphasizes applying advanced statistics, ensuring regulatory alignment, and communicating methodological justifications to diverse stakeholders.

Qualifications

• Demonstrated experience applying advanced statistical methodologies in biologics manufacturing.
• Strong background in statistical analysis for cell and gene therapy, mRNA products, or related biologics.
• Experience with analytical method transfer, forced degradation, and comparability studies.
• Proficiency in Python, R, or SAS.
• Understanding of regulatory expectations for statistical methods used in analytical studies and comparability assessments.
• Experience supporting regulatory submissions through statistical analysis, rationale, and interpretation.
• Strong communication, collaboration, and stakeholder-management skills.

Responsibilities

• Partner with CMC Statistical Sciences and Analytical Sciences & Technology teams to provide statistical expertise for biologics and vaccine development.
• Guide the statistical design, execution, and evaluation of analytical method transfer and forced degradation studies.
• Support comparability assessments and other scientific investigations using appropriate statistical methodologies.
• Develop, review, and communicate statistical analyses, interpretations, and technical justifications for regulatory submissions.
• Ensure statistical approaches align with applicable regulatory expectations and evolving industry guidance.
• Evaluate complex scientific data and recommend suitable statistical methods to support sound technical and regulatory decisions.
• Collaborate with cross-functional stakeholders to align on study strategies, analytical approaches, and interpretations of comparability.
• Influence decisions without direct authority and build consensus across multifunctional teams to support organizational objectives.

Skills

Biostatistics

Statistical modeling

Regulatory knowledge

Communication

Advanced statistics

Tools

Python

R

SAS

Job description

Seeking an experienced Statistical Consultant to support the global rollout of commercial vaccines manufactured using advanced mRNA technologies. This role will partner with CMC Statistical Sciences (CMCSS) and Analytical Sciences & Technology (AST) teams to provide statistical guidance for analytical method transfer, forced degradation, comparability studies, and other scientific investigations. The consultant will also contribute to regulatory submissions by developing or reviewing statistical methodologies, justifications, and study outcomes in alignment with current regulatory expectations.

Key Responsibilities:

• Partner with CMC Statistical Sciences and Analytical Sciences & Technology teams to provide statistical expertise for biologics and vaccine development.
• Guide the statistical design, execution, and evaluation of analytical method transfer and forced degradation studies.
• Support comparability assessments and other scientific investigations using appropriate statistical methodologies.
• Develop, review, and communicate statistical analyses, interpretations, and technical justifications for regulatory submissions.
• Ensure statistical approaches align with applicable regulatory expectations and evolving industry guidance.
• Evaluate complex scientific data and recommend suitable statistical methods to support sound technical and regulatory decisions.
• Collaborate with cross-functional stakeholders to align on study strategies, analytical approaches, and interpretations of comparability.
• Influence decisions without direct authority and build consensus across multifunctional teams to support organizational objectives.

Key Skills & Qualifications:

• Demonstrated experience applying advanced statistical methodologies in biologics manufacturing.
• Strong background in statistical analysis for cell and gene therapy, mRNA products, or related biologics.
• Experience with analytical method transfer, forced degradation, and comparability studies.
• Proficiency in statistical software or programming languages such as Python, R, or SAS.
• Understanding of regulatory expectations for statistical methods used in analytical studies and comparability assessments.
• Experience supporting regulatory submissions through statistical analysis, rationale, and interpretation.
• Strong communication, collaboration, and stakeholder-management skills.
• Ability to influence without authority and drive alignment across cross-functional teams.