A minimum of 6 years relevant experience in a clinical research
Oncology background/ experience an advantage but not a
Familiarity with complex statistical methods and regulatory requirements applicable to Phase I-IV clinical trials.
Good working knowledge of statistical software and programming languages such as SAS and other Microsoft applications for the design and analysis of clinical trials.
Excellent written and oral communication skills with good interpersonal
Demonstrate problem solving ability, critical thinking, flexibility, and ability to manage multiple projects with varying priorities.
Collaborate with Chief Investigators and academic institutions across Ireland in the development of investigator-led clinical trials, and with international collaborative groups as Group Statistician for Cancer Trials Ireland.
Accountable for selecting statistical methods for data analysis, authoring the corresponding sections of clinical trial protocols and statistical analysis plans. Accountable for conducting trial analyses and producing final statistical reports.
Contribute to strategic planning in Cancer Trials
Provide oversight of third party providers and statistical support for national cancer clinical trial group/unit investigators in the development and conduct of clinical trials.
Key member of study steering and oversight committees such as Safety Monitoring, Medical Oversight, Phase IB committees and Trial Steering Committee if applicable.
Provide statistical support to study design and protocol development/ amendments, including defining analysis populations, endpoint selection, statistical model specification and sample size
Provide statistical input to CRF and clinical database design, also data management processes up to Dry Run and Database Lock.
Oversee the randomisation and blinding process on applicable
Develop statistical analysis
Perform statistical analyses, including appropriate summaries of data and tests of
Write statistical reports or provide statistical contribution to integrated clinical
Produce and present reports required for regular study steering and oversight
Support Clinical Operations team during the study life cycle in the determination of the evaluability of study subjects, risk assessment and management, and major protocol deviation
Contribute to publications in leading international high impact medical journals and input into meeting and symposia abstracts, posters and presentations.
Perform or oversee meta-analyses on pooled data from multiple
Maintain the statistical components of Trial Master
Ensure statistical methods and procedures adhere to regulatory guidelines and company
Responsible for the quality and timely completion of all statistical tasks and
Oversee the statistical programmers ensuring robust quality control processes in
Participate and represent Cancer Trials Ireland in audits and regulatory
Keep abreast of new statistical concepts and techniques and changes in regulatory
Lead development and update of internal statistical guidelines and SOPs and contribute to development and update of relevant internal guidelines and SOPs.