Group Statistician (GS) – Cancer Trials Ireland
- PhD. or Masters degree in Biostatistics.
- 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.
- Provide relevant statistical training to
Cancer Trials Ireland
To Apply and for more Infomration Contact:
Patricia Dignam, HR Manager: email@example.com
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