Principal Biostatistician – Chemistry, Manufacture and Control (CMC)
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Job Description
Principal CMC Biostatistician providing statistical support across pharmaceutical manufacturing processes. Strong focus on analytics, regulatory compliance, and collaboration with interdisciplinary teams.
Responsibilities:
- The Principal CMC Biostatistician is responsible for providing statistical support for a wide range of activities pertaining to pharmaceutical manufacturing.
- Strong experiences in end‑to‑end statistical support across the product lifecycle, including analytical method development and validation, formulation development and robustness, and process development and validation—aligned with regulatory standards such as FDA, EMA, ICH, and USP.
- Good oral and written skills are crucial, as is the desire to learn enough of the relevant science to interact effectively.
- Exposure to modern data analysis techniques and experiences such as data visualization, robust statistics and analysis of high-dimensional data is desirable.
- Must enjoy the process of building long-term collaborative relationships, be at ease with either a non-rigid or rigid structure to projects and be organized in handling numerous projects simultaneously.
Requirements:
- PhD in Statistics or related field
- Strong experience in Statistical Support of CMC is a must
- Solid knowledge of linear mixed models, multivariate analysis, design of experiments and Bayesian statistics is essential.
- Proficiency in the R language is required with the development of automated, reproducible workflows using R Markdown and Quarto to enhance regulatory submission readiness.
- Demonstrated written, oral, and personal communication skills.
- Ability to work autonomously and within a team environment.
- Demonstrated ability to work in interdisciplinary contexts outside statistics.
Benefits:
- Health insurance
- Professional development opportunities
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