We are seeking a talented Statistical Consultant to support the development and manufacturing of both biological and chemical molecules. Your expertise will contribute to method development, robustness, equivalence, validation, specification determination, process optimization, and control in a pharmaceutical CMC (Chemistry, Manufacturing, and Controls) context.
Key Responsibilities
In this role, you will:
- Design experiments and conduct statistical analyses to support product development and manufacturing processes.
- Prepare clear, concise reports and presentations for internal stakeholders and regulatory authorities.
- Review technical reports for statistical and mathematical accuracy.
- Participate actively in project meetings to contextualize statistical applications.
- Manage multiple projects simultaneously, ensuring deadlines are met and deliverables are of high quality.
- Continuously enhance your statistical expertise through research, training, and other resources.
Qualifications
- A Master’s degree in Statistics (a Bachelor’s in Mathematics is preferred); a Ph.D. in Statistics is an advantage.
- 2–4 years of experience as a statistician in pharmaceutical product development.
- Proficiency in statistical methods, including DOE (Design of Experiments), regression modeling, variance analysis, multivariate analysis, process capability, control charts, and equivalence testing.
- Familiarity with Bayesian statistics is a bonus.
- Advanced programming skills in tools such as R, JMP, and SAS (base/stat). Knowledge of Python or other statistical packages is an asset.
Core Competencies
- Strong verbal and written communication skills.
- Ability to work independently and collaborate effectively in a team setting.
- Proven ability to manage multiple projects in a dynamic environment.
- Curious, detail-oriented, and solution-driven.
- Organizational skills and a customer-focused approach.
- Experience working on multidisciplinary projects.
- Fluent in English; proficiency in French is a plus.
What We’re Looking For
We’re looking for someone adaptable, with a genuine interest in building a broad understanding of various pharmaceutical domains, including bioassays, analytical chemistry, process chemistry, and packaging. You’ll need to be flexible, organized, and capable of tackling diverse challenges across multiple areas simultaneously.