Quantitative Researcher

2 days ago


Newry, United Kingdom CPL Full time
Senior Biostatistician
Are you a skilled biostatistician seeking a challenging role in pharmaceutical development? We are looking for an experienced quantitative researcher to join our R&D Department. This position 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

We are offering a competitive salary of $90,000 per annum. The successful candidate will have a relevant statistics, biostatistics, data science or maths degree (with statistical focus) and at least 5 years expertise in statistical programming (e.g. SAS, R, Python or similar statistical programmes). If you are passionate about biostatistics and have excellent analytical skills, please get in touch with us.