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Statistical Consultant

Intellectt INC

  • NULL, NJ
  • 18 days ago
  • Remote
  • $49–$59

Highlights

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. 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.

Numbers & Facts

LocationNULL, NJ (
Remote)
Salary$49–$59

Description

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

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