MCS Group are delighted to be working with a Large Pharmaceutical Company based in Newry in adding a Biostatistician to their R&D Team.
An excellent opportunity has arisen within the Research & Development Department for a highly motivated and ambitious Data Analyst - Biostatistician to become part of our successful clinical research team.
The successful candidate will be a key member of the R&D team and be responsible for analysing data obtained from veterinary clinical/pre-clinical studies and pharmaceutical development, working in a GLP/GMP environment to exact regulatory standards.
Main Activities/Tasks
* 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.
* Create and review programming specifications for analysis of datasets.
* Author, review and follow SOPs (FDA, EMA, VICH etc). Maintain in-depth knowledge of regulatory guidance (FDA, EMA, VICH) and GLP requirements to ensure continued compliance of statistical methods and approaches.
* Provide technical support throughout the lifecycle of the New product projects.
* Provide technical support to provide direction and assist in root cause analysis.
* Attend regulatory agency meetings/respond to queries to deliver statistical analysis of results for regulatory studies/submissions.
* Maintain up to date, accurate, organised project documentation ensuring Audit readiness at all times. Keep project team members informed of progress and statistical outcomes and risks.
Essential Criteria
* 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.
* Highly motivated, demonstrate excellent organisational and planning skills within a team environment.
* Excellent verbal & written communication skills. Highly proficient in Microsoft Office packages.
What is in it for you?:
* Excellent Career Development Opportunities.
* Competitive salary.
* Free On-site Parking.
To speak in absolute confidence about this opportunity please send an up-to-date CV via the link provided or contact Zachery Downes, specialist recruitment consultant at MCS Group.
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