With over 50 years in business, our client is one of Northern Ireland’s leading companies and an industry leader across the world in pharmaceutical development.
This position within the R&D Department supports the clinical research team by conducting statistical analyses for veterinary clinical/pre-clinical studies and pharmaceutical development in compliance with GLP/GMP standards and regulatory guidelines.
Key Responsibilities:
- Serve as a statistical advisor for pre-clinical, clinical, and pharmaceutical studies.
- Design and prepare Statistical Analysis Plans for study protocols.
- Analyse study data using regulatory-approved statistical methods, interpret results, and compile detailed reports with clear conclusions.
- Perform data mining, cleaning, and visualization to support study insights.
- Create and review programming specifications for dataset analysis.
- Author, review, and adhere to SOPs based on FDA, EMA, and VICH guidelines.
- Ensure compliance with regulatory and GLP requirements in statistical approaches.
- Provide technical support for new product development projects and assist in root cause analysis.
- Respond to regulatory agency queries, presenting statistical results for submissions.
- Maintain accurate project documentation to ensure audit readiness.
- Update team members on statistical progress, outcomes, and potential risks.
What we are looking for;
- A relevant statistics, biostatistics, data science or maths degree (with statistical focus)
- At least 5 years expertise in statistical programming (e.g. SAS, R, Python or similar statistical programmes)
- At least 5 years’ experience in clinical/pre-clinical statistics to include development of protocol design, sample size calculation, sampling plan, statistical plan and modelling (including mixed modelling), ANOVA.
- Experience developing custom programming codes to generate summary tables, data listings, graphs and derived datasets as specified in statistical plan.
- Expertise in analysing large databases to support Clinical and Pharmaceutical research in new product development.
- Demonstrate understanding and use of Design of Experiments (DOE) principles to support Clinical, Pharmaceutical and Analytical Development
- Proven ability to provide on time deliverables in multiple projects at various stages of development,
- Proven ability to work effectively in a team environment and with minimal technical guidance
If this sounds like an opportunity that could potentially be of interest to you, simply get in touch with Nathaniel Ferris by applying to this advertisement or giving me a call.