Clinical Research Statistician

2 days ago


Newry, United Kingdom CPL Full time
Senior Biostatistician Role
At CPL, we're seeking a highly skilled Senior Biostatistician to support our clinical research team. This is an excellent opportunity to utilize your statistical expertise in pharmaceutical development.

About the Role
This position involves conducting statistical analyses for veterinary clinical/pre-clinical studies and pharmaceutical development, ensuring compliance with GLP/GMP standards and regulatory guidelines. Key Responsibilities include:
  • Serving as a statistical advisor for pre-clinical, clinical, and pharmaceutical studies
  • Designing and preparing Statistical Analysis Plans for study protocols
  • Analysing study data using regulatory-approved statistical methods, interpreting results, and compiling detailed reports with clear conclusions
  • Performing data mining, cleaning, and visualization to support study insights
  • Creating and reviewing programming specifications for dataset analysis
  • Authoring, reviewing, and adhering to SOPs based on FDA, EMA, and VICH guidelines
  • Ensuring compliance with regulatory and GLP requirements in statistical approaches

Requirements
We're looking for a candidate with a relevant statistics, biostatistics, data science or maths degree (with statistical focus) and at least 5 years' experience in statistical programming (e.g. SAS, R, Python or similar statistical programmes). You should also have expertise in analysing large databases to support Clinical and Pharmaceutical research in new product development.
The estimated salary for this role is $85,000 - $110,000 per annum, depending on experience.

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