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.


reas 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.


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
dditional Job Requirements:
None

Job Tags

Worldwide,

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