Note: The job is a remote job and is open to candidates in USA. Novozen Healthcare LLC is seeking a Statistical Consultant to support the global rollout of commercial mRNA vaccines. The role focuses on statistical support for 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
Skills
- 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
- Strong communication, collaboration, and stakeholder management skills
- Applicants must be authorized to work in the United States
- 7+ years of relevant statistical consulting experience preferred
Benefits
- Eligible employees may enroll in and receive benefits offered by NovoZen Healthcare LLC, subject to applicable plan terms, eligibility criteria, and contribution requirements.
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