Senior Bio Statistician – Data Analyst

Job Overview

An excellent opportunity has arisen within our clients Research & Development Department for a

highly motivated and ambitious Senior level Data Analyst –Bio Statistician to become part of the 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 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.

Duration: Full Time, Permanent with 2 days working from home

Location: Newry

Benefits:

• Free Life Assurance

• Company Pension Scheme

• Healthcare cash plan

• 32 days annual leave

• Wedding Leave

• Company Sick Pay

• Employee well-being initiatives

• Employee Assistance Programme

• On-site free parking

• Canteen Facilities

• Employee Perks scheme

• Employee Recognition scheme

• Career development opportunities