Job Description

Job Description: CMC Statistician
Client Hybrid role, Devens OR New Brunswick site
Work Schedule: Mon - Fri, Business hours

This position is responsible for providing statistical analysis to service clients in Global Product Development & Supply (GPS).

Major Duties and Responsibilities:

The successful candidate will provide statistical support to Global Product Development & Supply (GPS) in Analytical Strategy & Operations and Manufacturing Science & Technology to ensure product quality, process productivity, robustness, and compliance.

Areas of support include stability analysis, specification setting, statistical application in manufacturing processes, health authority filings, and regulatory responses.

This role offers the opportunity to support the Client product portfolio worldwide with functions in small molecule and biologics development, manufacturing, and supply.

Key Requirements:
- Extensive knowledge of statistical methodologies, including regression, ANCOVA, Monte Carlo simulation,
tolerance interval, design of experiment (DOE), and statistical modeling.
- Familiar with or able to develop an understanding of pharmaceutical stability data and how it is generated and
used, e.g. ICH stability guidances particularly statistical analysis for shelf life (ICH Q1E)
- General familiarity with the types of chemical/biochemical analyses, the data variability, and good manufacturing
practices common in the pharmaceutical industry.
- Able to help in the design of stability studies using matrixing and bracketing (ICH stability guidance Q1D) and,
where needed, advise in the design of experiments to reduce testing.
- Knowledge of pharmaceutical product shelf-life and specification.
- Experience in extracting data from a variety of sources, databases, and documents.
- Good communication, presentation, and technical writing skills.
- Ability to effectively communicate and explain statistical technical information to non-statistician colleagues.
- Ability to work independently as well as effectively collaborate with cross-functional teams.

Job Tags

Worldwide,

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