
Location
Hybrid
Hybrid

Contract Type
Permanent part time/ fulltime
Permanent part time/ fulltime

Closing Date
31st December 2022
31st December 2022
Reports to:
Head of Biometrics (HoB)
Key Requirements
- Ph.D or Masters degree in Biostatistics.
- A minimum of 6 years relevant experience in a clinical research setting.
- Oncology background/ experience an advantage but not a necessity.
- 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 skills.
- Demonstrate problem solving ability, critical thinking, flexibility, and ability to manage multiple projects with varying priorities.
Main Function(s)
- 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 Ireland.
- 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.
Primary Responsibilities
- Provide statistical support to study design and protocol development/ amendments, including defining analysis populations, endpoint selection, statistical model specification and sample size calculation.
- 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 studies.
- Develop statistical analysis plans.
- Perform statistical analyses, including appropriate summaries of data and tests of hypotheses.
- Write statistical reports or provide statistical contribution to integrated clinical reports.
- Produce and present reports required for regular study steering and oversight committees.
- 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 review.
- 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 studies.
- Maintain the statistical components of Trial Master Files.
- Ensure statistical methods and procedures adhere to regulatory guidelines and company requirements.
- Responsible for the quality and timely completion of all statistical tasks and deliverables.
- Oversee the statistical programmers ensuring robust quality control processes in place.
- Participate and represent Cancer Trials Ireland in audits and regulatory inspections.
- Keep abreast of new statistical concepts and techniques and changes in regulatory requirements.
- 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 organisation.