JOB DESCRIPTION. Northern Ireland Clinical Trials Unit (NICTU), The Royal Hospitals, Belfast. Biostatistician / Senior Biostatistician

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1 JOB DESCRIPTION POST: LOCATION: Junior Biostatistician Northern Ireland Clinical Trials Unit (NICTU), The Royal Hospitals, Belfast BAND: 5 CONTRACT TYPE: RESPONSIBLE TO: REPORTS TO: 3 years Clinical Trials Unit (CTU) Director Biostatistician / Senior Biostatistician BACKGROUND The Northern Ireland Clinical Trials Unit (NICTU) is funded by the Public Health Agency (PHA), Health and Social Care (HSC) Research and Development Division and is a UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Unit (CTU). The CTU works with HSC and University partners, providing the infrastructure to undertake multi-centre clinical trials. JOB SUMMARY/MAIN PURPOSE As Junior Biostatistician you will be responsible for many aspects of the NICTU statistics service. You will interface with internal and external clients to direct the development, conduct and analysis of clinical trials and other well designed studies. You will assist the biostatistician and senior biostatistician in managing daily operations to ensure compliance with sponsor and regulatory requirements, timelines and budgets. You will assist the biostatistician and senior biostatistician in determining priorities and resource requirements. You will act as trial statistician in projects with a high degree of autonomy but will be expected to highlight and discuss issues with the biostatistician, senior biostatistician, Director and CTU Manager. You would be expected to travel and be willing to work flexible hours to meet the requirements of the job.

2 MAIN DUTIES/RESPONSIBILITIES Trial Management and Conduct Contribute to the development and management of clinical research protocols as a key member of the Trial Management Group. This contribution ranges from research concept, through design and conduct, to analysis and reporting. Develop and maintain efficient communications with the multidisciplinary team (CTU staff, funders, sponsors, investigators and other key stakeholders). Responsibility for writing and/or reviewing the content and feasibility of statistical sections of new or amended protocols, forms, documents and reports. Liaise with biostatistician / senior biostatistician during randomisation processes, writing statistical analysis plans, and analysis of data. Be involved in the design of case report forms (CRF), clinical trial data management systems archiving and data quality control as required by investigators and sponsors. This includes approval of clinical trial documentation. Use a variety of statistical software packages and general office systems (including but not limited to STATA, SPSS, R and Microsoft Office) to undertake the analysis for and reporting of clinical trials. Support the activities of the trial management groups, trial steering committees and data monitoring committees, writing reports to oversight groups, sponsors, funders and other stakeholders as appropriate. Contribute to the management of selected clinical trials, meetings, reports and other activities of high importance and/or complexity. This will generally include new trials, negotiation with external bodies and overseeing set up and progress of clinical trials. Implement methodologies for the analysis and/or interpretation of data and contribute to the implementation of methodologies for more complex clinical trials. Resource and Finance Management Assist in the delivery of CTU educational courses and training programmes in the design, conduct and analysis of clinical research. Participate in continuing professional development as appropriate, disseminating new knowledge and providing training to other staff as

3 required. The post holder will be expected to develop his/her o wn research portfolio. Quality Assurance and Regulation Maintain an understanding of regulatory requirements, Good Clinical Practice (GCP) and research governance and the impact on CTU activities. Contribute to the CTU quality management system, reviewing and writing SOPs and developing procedural documentation as applicable. Ensure trials in the portfolio are conducted according to GCP guidelines, regulatory requirements and applicable CTU/sponsor policies, SOPs and working procedures. Facilitate and participate in internal audits and in audits by representatives from external bodies (sponsor and regulatory authorities). Communication and Networking To synthesise and assimilate highly complex information and evidence and present it clearly and precisely both verbally and in writing. Present complex and sometimes conflicting or contentious results of evaluations. Develop statistical processes and models of working through membership of appropriate working groups. Have a knowledge of statistical techniques (specifically as it applies to clinical trials). Assist in introducing, adapting and improving systems to input, store and disseminate clinical trial data. Responsible for one or more information systems for collection of statistical data. Represent the CTU on trial committees and research groups and attend regional, national and international events/conferences. Any other duties relevant to the post which may arise and as requested by the biostatistician / senior biostatistician / Director of the CTU. General Responsibilities Employees of the Trust are required to promote and support the mission and

4 vision of the service for which they are responsible and: - At all times provide a caring service and to treat those with whom they come into contact in a courteous and respectful manner. - Demonstrate their commitment by their regular attendance and the efficient completion of all tasks allocated to them. - Comply with the Trust's Smoke Free Policy. - Carry out their duties and responsibilities in compliance with the Health and Safety Policies and Statutory Regulations. - Adhere to Equality and Good Relations duties throughout the course of their employment. - Ensure the ongoing confidence of the public in-service provision. - Maintain high standards of personal accountability. - Comply with the HPSS Code of Conduct. Records Management Used as part of their business within the Belfast Health and Social Care Trust, including patient/client, corporate and administrative records whether paper based or electronic and also including s. All such records are public records and are accessible to the general public, with limited exceptions, under the Freedom of Information Act 2000, the Environment Regulations 2004 and Data Protection Act Employees are required to be conversant with the Belfast Health and Social Care Trust policy and procedure on records management and to seek advice if in doubt. Environmental Cleaning Strategy The Trusts Environmental Cleaning Strategy recognizes the key principle that Cleanliness matters is everyone s responsibility, not just the cleaners Whilst there are staff employed who are responsible for cleaning services, all Trust staff have a responsibility to ensure a clean, comfortable, safe environment for patients, clients, residents, visitors, staff and members of the general public. Infection Prevention and Control The Belfast Trust is committed to reducing Healthcare associated infections (HCAIs) and all staff have a part to play in making this happen. Staff must comply with all policies in relation to Infection Prevention and Control and with ongoing reduction strategies. Standard Infection Prevention and Control Precautions must be used at all times to ensure the safety of patients and staff. This includes:-

5 Cleaning hands either with soap and water or a hand sanitiser at the appropriate times (WHO 5 moments ); Using the correct 7 step hand hygiene technique; Being bare below the elbows when in a clinical environment; Following Trust policies and the Regional Infection Control Manual (found on intranet); Wearing the correct Personal Protective Equipment (PPE); Ensuring correct handling and disposal of waste (including sharps) and laundry; Ensuring all medical devices (equipment) are decontaminated appropriately ie cleaned, disinfected and/or sterilised; Ensuring compliance with High Impact Interventions. Clause: This job description is not meant to be definitive and may be amended to meet the changing needs of the Belfast Health and Social Care Trust.

6 JOB SPECIFICATION POST: LOCATION: Junior Biostatistician Northern Ireland Clinical Trials Unit (NICTU), The Royal Hospitals, Belfast ESSENTIAL CRITERIA 1. BSc (Hons) in Statistics OR Mathematics with Statistics OR other subject with a substantial statistical component 2. Ability to demonstrate practical use of information technology systems, in particular a variety of statistical software applications and Microsoft office packages including Word, PowerPoint and Excel, and internet 3. Ability to communicate effectively (both orally and written) with professional and non-professional staff 4. Ability to work as part of a team 5. Willingness to develop skills and keep up to date with best practice 6. Willingness to travel if required 7. Willingness to work flexibly to meet the needs of the job DESIRABLE CRITERIA 1. Experience in the conduct of clinical trials or epidemiological research 2. Sound knowledge of both national and local clinical research legislation including Good Clinical Practice Guidelines and research governance.

7 NOTE: Where educational/professional qualifications form part of the criteria you will be required, if shortlisted for interview, to produce original certificates, and one photocopy of same, issued by the appropriate authority. Only those certificates relevant to the shortlisting criteria should be produced. If educational certificates are not available an original letter and photocopy of same detailing examination results from your school or college will be accepted as an alternative. If successful you will be required to produce documentary evidence that you are legally entitled to live and work in the United Kingdom. This documentation can be a P45, payslip, National Insurance Card or a birth certificate confirming birth in the United Kingdom or the Republic of Ireland. Failure to produce evidence will result in a non appointment.