Job Title: CMC Statistician
Location: Hybrid role, Devens, MA
Work Schedule: Monday – Friday, Business hours
Job Description:
- Join our team as a CMC Statistician, where you’ll provide vital statistical analysis to support our Global Product Development & Supply (GPS) clients. This role offers the opportunity to contribute to our product portfolio worldwide, focusing on small molecule and biologics development, manufacturing, and supply.
Job Responsibilities:
- Provide statistical support to ensure product quality, process productivity, robustness, and compliance.
- Support areas including stability analysis, specification setting, statistical application in manufacturing processes, health authority filings, and regulatory responses.
- Assist in the design of stability studies and advise on experiment design to reduce testing.
- Extract data from various sources, databases, and documents for analysis.
Skills Required:
- M.S. with a minimum of 2 years’ experience or Ph.D. in Statistics, Applied Mathematics, Data Science, or Engineering majors with significant training in Statistics/Advanced Analytics.
- Proficiency in major statistical software packages and programming languages (e.g., R, JMP, MINITAB, or SAS).
- Extensive knowledge of statistical methodologies, including regression, ANCOVA, Monte Carlo simulation, tolerance interval, design of experiment (DOE), and statistical modeling.
- Familiarity with pharmaceutical stability data and its application, e.g. ICH stability guidances particularly statistical analysis for shelf life (ICH Q1E).
- Knowledge of pharmaceutical product shelf-life and specification.
- Excellent communication, presentation, and technical writing skills.
- Ability to work independently and collaborate effectively with cross-functional teams.
Desired Experience / Knowledge:
- Experience in the pharmaceutical or biotechnology industries.
- Familiarity with Bayesian statistics.
- Background in sciences to facilitate a subjective understanding of the problems.
- Experience working with a diverse range of technically and culturally diverse individuals.
About SSi People:
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.