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.
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
...Special Education Administrator Full time Special Education Administrator with Woodford County Special Education Association. 195 day contract. Benefit package including health/life, dental and vision options, and professional development. Duties include, but are not...
...and customer service, and were building a team that reflects those same values. Do you have experience safely operating equipment and maintaining plant safety in an aggregate environment? We are hiring an Aggregate Plant Operator for our Bridgeport site. If you have...
...Disney Imagineering Live, LLC is seeking a skilled Costume Designer to develop imaginative, one-of-a-kind costumes for Disney Live Entertainment supporting Disney Cruise Line. The role requires translating creative concepts into practical solutions aligned with budgets...
...pm Tuesdays, Thursdays, & Fridays 9am-3pm Join our state of the art, federally registered apprentice program as a Mechanical Insulator and play a vital role in enhancing building efficiency and safety! In this energetic position, you will be responsible for...
...A well-known law firm is looking for a Washington licensed attorney with at least five years of experience litigating to assist with... ...employment and/or personal injury litigation matters on a completely remote basis. This can be a contract or permanent position depending...