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:
1. Provide statistical support across Global Product Development & Supply team to ensure robust processes, analytical methods, and product quality.
2. Design, analyze, and interpret studies related to analytical methods, stability programs, process validation, tech transfer, and manufacturing operations.
3. Develop and apply advanced statistical and machine learning models (e.g., regression, clustering, deep learning) to support product and process understanding.
4. Perform data analysis and visualization using statistical software such as SAS, R, Python, or JMP to support decision-making and regulatory submissions.
5. Support regulatory filings and responses, including preparation of statistical justifications and documentation for health authorities.
6. Partner with cross-functional teams in small-molecule and biologics development, manufacturing, and supply to define study objectives and ensure statistically sound approaches.
7. Provide consultation on experimental design and contribute to the development of statistically rigorous protocols and reports.
8. Ensure compliance with internal quality standards and regulatory expectations, particularly regarding statistical methods and data integrity.
9. Communicate complex statistical concepts in a clear, concise, and actionable manner to both technical and non-technical stakeholders.
10. Contribute to continuous improvement initiatives, including developing best practices, tools, and templates for statistical analysis within the organization.
11. Work independently while managing multiple projects, ensuring timely and high-quality deliverables in a global, matrixed environment.
Requirements:
12. 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.
13. 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.
14. Strong data analysis and programming skills. Proficient with major statistical software packages such as SAS, R, Python or JMP.
15. Great communication, presentation, and technical writing skills. Ability to effectively communicate technical information in an understandable, rational, and concise manner.
16. Able to work independently as well as effectively collaborate with cross-functional teams.
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