- Full-time
- Newry
Job Category: Pharmaceuticals
Website SEDA Talent
Statistician
Newry
SEDA Talent are recruiting a Statistician to join the team at one of the country’s largest and most successful FMCG business’ in Newry.
The successful candidate will be a key member of the R&D team and be responsible for analysing data obtained from clinical/pre-clinical studies and pharmaceutical development, working in a GLP/GMP environment to exacting regulatory standards.
Key Responsibilities:
- Act as statistical advisor and statistician on scientific studies conducted within the R&D facility (including pre-clinical/clinical and pharmaceutical development).
- Design and prepare Statistical Analysis Plans for inclusion in study protocols.
- Statistical analysis of study data according to protocol using internationally regulatory approved statistical methods
- Assessment and interpretation of results, compilation of statistical analysis reports including clear statistical conclusions.
- Capability for data mining, data cleaning and data visualisation reporting techniques
- Maintain in-depth knowledge of regulatory guidance (FDA, EMA, VICH) and GLP requirements to ensure continued compliance of statistical methods and approaches
The Ideal Candidate:
- 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
This role requires an onsite presence and comes with a competitive salary & benefits package.
For further details please apply directly below or contact me on 208 9601 6225