Senior Biostatistician- Clinical and Pharmaceutical Research

Job title:

Senior Biostatistician- Clinical and Pharmaceutical Research

Company:

Norbrook Laboratories

Job description

Job Description: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.

Expected salary

Location

Newry

Job date

Thu, 05 Dec 2024 05:04:34 GMT

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