Statistical Consultant

Job Title: Statistical Consultant
Location: 100% Remote
Employment Type: Contract (W2)
Duration: 6+ months Job Summary

Seeking an experienced Statistical Consultant to support the global rollout of commercial mRNA vaccines, focusing on biologics manufacturing, analytical method transfer, comparability studies, and regulatory submissions.

Responsibilities

• Collaborate with CMC Statistical Sciences and Analytical Sciences & Technology teams.

• Guide the design and execution of analytical method transfer and forced degradation studies.

• Apply advanced statistical methods to support biologics manufacturing and comparability assessments.

• Develop statistical rationales and contribute to regulatory submission documents.

• Ensure statistical approaches align with regulatory expectations.

• Work with cross-functional teams to support project objectives and build consensus.

Key Requirements

• 7+ years of relevant statistical consulting experience preferred.

• Experience in biologics manufacturing, particularly mRNA products or cell and gene therapy.

• Proficiency in Python, R, or SAS.

• Knowledge of analytical method transfer, comparability studies, and advanced statistical methodologies.

• Understanding of regulatory expectations for pharmaceutical development and manufacturing.

Pay Scale
Anticipated hourly pay range: specific range such as ($49/hr to $59/hr).

Benefits
Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws