Job Profile & Summary:
Our highly regarded biologics client is seeking a motivated Statistician for a 12 month contract post. This is a junior level role so if you have a passion for data analysis and a third level degree in the subject along with a keen interest in working in the life-sciences sector please reach out today for more information.
The successful candidate will provide statistical support to Global Product Development & Supply team to deliver process and method robustness in ensuring product quality and compliance.
Responsibilities:
- Provide statistical support across Global Product Development & Supply team to ensure robust processes, analytical methods, and product quality.
- Design, analyze, and interpret studies related to analytical methods, stability programs, process validation, tech transfer, and manufacturing operations.
- Develop and apply advanced statistical and machine learning models (e.g., regression, clustering, deep learning) to support product and process understanding.
- Perform data analysis and visualization using statistical software such as SAS, R, Python, or JMP to support decision-making and regulatory submissions.
- Support regulatory filings and responses, including preparation of statistical justifications and documentation for health authorities.
- Partner with cross-functional teams in small-molecule and biologics development, manufacturing, and supply to define study objectives and ensure statistically sound approaches.
- Provide consultation on experimental design and contribute to the development of statistically rigorous protocols and reports.
- Ensure compliance with internal quality standards and regulatory expectations, particularly regarding statistical methods and data integrity.
- Communicate complex statistical concepts in a clear, concise, and actionable manner to both technical and non-technical stakeholders.
- Contribute to continuous improvement initiatives, including developing best practices, tools, and templates for statistical analysis within the organization.
- Work independently while managing multiple projects, ensuring timely and high-quality deliverables in a global, matrixed environment.
Requirements:
- Masters in a STEM major with significant academic training in statistics and machine learning methodologies or a third level degree in statistics or data analytics.
- Extensive knowledge on statistical and machine learning methodologies, such as data distributions, regression, deep learning, and clustering. General knowledge of biologics/chemical engineering is a plus.
- Strong data analysis and programming skills. Proficient with major statistical software packages such as SAS, R, Python or JMP.
- Great communication, presentation, and technical writing skills. Ability to effectively communicate technical information in an understandable, rational, and concise manner.
- Able to work independently as well as effectively collaborate with cross-functional teams.
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