Principal Biostatistician - Nonclinical & Manufacturing Statistics (FSP)
- Leading multiple nonclinical or manufacturing statistics supporting a big pharmaceutical company.
- Responsible for rigorous statistical methods to design experiments, analyze complex biological data, and support decision-making throughout the early drug development process
- Collaborate closely with scientists, toxicologists, regulatory experts, and data teams to ensure high-quality, interpretable results that accelerate the development of new medicines.
- 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.
- Constantly eager to expand statistical, communications, and computing expertise.
- 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.
- PhD in Statistics or related field
- 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.
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