Senior Biostatistician

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

Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs www.mcsgroup.jobs