CMC Statistician in Devens, MA

Client Hybrid role, Devens OR New Brunswick site

CMC Statistician

Top 3 Must Have's to be considered for this role:

• 2+years of statistical analysis experience in Biopharma or Phd
• ICH guidelines
• Stability Data, Specification

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.

Qualifications:

• M. S. with a minimum of 2 years’ experience or Ph. D. in Statistics, Applied Mathematics, Data Science, or
• Engineering majors with significant academic training in Statistics/Advanced Analytics.
• Proficiency in major statistical software packages and programming languages (e.g., R, JMP, MINITAB, or SAS).

Experience / Knowledge Desired:

• Knowledge and experience in pharmaceutical or biotechnology industries.
• Familiarity with Bayesian statistics.
• Some background in sciences to facilitate a subjective understanding of the problems.
• Experience in working with a wide range of technically and culturally diverse individuals.

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