Senior Biostatistician- Clinical and Pharmaceutical Research

Job ref: S101024 Job type: Permanent Location: Newry Closing date: Friday 13 Dec 2024 13:00 An excellent opportunity has arisen within our Research & Development Department for a highly motivated and ambitious Data Analyst - Statistician to become part of our successful clinical research team. The successful candidate will be a key member of our 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 exacting 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. The successful candidate will demonstrate strong attention to detail, with high levels of accuracy and precision in recording/ reporting results 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 Desirable Criteria: Postgraduate qualification in statistics or other relevant degree Professional certification Knowledge of statistical regulatory requirements (FDA, EMA, VICH) for analysing data from clinical studies Experience in researching and implementing new statistical methods for various types of data Experience in attending regulatory agency meetings/responding to regulatory body queries on statistical plan and analysis. To Apply Please forward your CV via the APPLY Now button below.