Job Title: Statistical Consultant
Company: Novozen Health Care LLC.,
Location: Remote
Employment Type: Contract
Job Responsibilities:
Seeking an internal statistical consultant to support global rollout of commercial vaccines produced via best-in-class mRNA manufacturing technologies. The candidate will liaise between CMC Statistical Sciences (CMCSS) and Analytical Sciences & Technology (AST) functions to guide AST on statistically appropriate design & execution of analytical method transfer studies, forced degradation studies, and other scientific inquiries in accordance with regulatory expectations. In this capacity the candidate will be expected to directly generate and/or inform the content of regulatory submissions which include detailed rationale and outcomes of applied statistical methodologies. The candidate should also have and maintain awareness of the latest regulatory thinking on the use of statistical methods to support method transfer and comparability studies, and be capable of navigating varying understandings of "comparability" within this context.
Required Qualifications:
Demonstrable experience working with sophisticated statistical methodologies in the context of biologics manufacturing, particularly as applied to cell/gene therapy or mRNA products.
Demonstrable literacy in working with statistical software and/or programming languages, specifically Python, R, or SAS.
Must be comfortable with and competent in influencing without authority; working in multifunctional groups to generate consensus and movement toward the organization's stated strategic objectives.
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.