For appointment as CTU Statistician (grade 6), the post holder will work under the supervision and guidance of a more experienced statistician.

Transcription

1 Norwich Medical School Norwich Clinical Trials Unit CTU Statistician Ref: RA1153 This is a full time post, until November The Post The primary purpose of this role is to work with a Senior Trial Statistician providing statistical support for 2 major grant funded trials within the Norwich Clinical Trials Unit and those in development. The post holder will have extensive contact with Trial Managers, Data Managers, and Database Programmers within the CTU. The successful candidate would also be expected to provide advice on research applications as part of the NIHR East of England Research Design Service. For appointment as CTU Statistician (grade 7), the successful applicant will be required to independently carry out the majority of duties listed in the job description below. For appointment as CTU Statistician (grade 6), the post holder will work under the supervision and guidance of a more experienced statistician. Job Description Main duties and responsibilities include: Providing day to day support for the statistical aspects of specific Norwich CTU trials including 2 recently funded respiratory trials. Developing statistical analysis plans and working procedures including the statistical master file. Assisting in the development of case report forms and specifications for analysis datasets, and, in collaboration with Database Programmers, the study database. Liaising with trial and data managers and programmers about data quality and missing data.

2 Ensuring deadlines and project milestones relating to data and analyses are met, coordinating with other members of staff and external collaborators as necessary. Providing statistical input for decisions about trial and data management, drawing attention to potential problems in terms of data quality and analysis which could impact on final results of the trial. Scheduling, presentation and preparation of reports of analyses for independent Data Monitoring Committees and Trial Steering Committees. Discussion and interpretation of results with colleagues and collaborators in the trial. Assisting in the preparation of conference abstracts and papers for submission to peer reviewed journals. Providing advice and research design support for research applications as part of the NIHR East of England Research Design Service (RDS) The post holder will be expected to: Develop their knowledge of the biology and epidemiology of relevant disease areas by reading relevant journals, attending conferences, etc. Take an active role within the trial team in the application of all relevant regulatory and governance procedures including the UK Clinical Trial Regulations, GCP and the NHS Research Governance Framework. Ensure compliance, themselves and by the Trial Team with all relevant SOPs, Working Practice Documents and training requirements as documented in the CTU Staff Training Matrix. Take responsibility for the quality of their own work and contributing to the development of the overall CTU Quality Management System. Ensure the quality of the trial through engagement with trial team activities and contributing to resolving statistical problems identified in monitoring and audit reports. Escalating potentially significant problems to the Senior Trial Statistician. Contribute to the overall work of the unit in addition to participating in CTU committees and groups including the Protocol Review Committee. Contribute to teaching activities in the Faculty.

3 The post holder will be encouraged to work on methodological problems, in collaboration with interested colleagues, which are of practical relevance to the work of the Unit. Appointees at grade 6 will have the opportunity to contribute to the development of new research proposals, including study design and sample size calculations. Appointees at grade 7 will also have the opportunity to contribute fully to the development of new research proposals and funding applications as coapplicant. Opportunities exist to participate in the statistical review of papers. As part of career development the post holder will be encouraged to work towards opportunities for a PhD and will carry out other duties which are within the scope, spirit and purpose of the role description as requested by the CTU Director, Head of Statistics or Head of School. This role description is not intended to be exhaustive and it is likely that duties and responsibilities may be altered from time to time in the light of changing circumstances. Audit and Inspections In the event of statutory inspection (MHRA) for GCP, the post holder will be expected to contribute to and participate in the preparation for the inspection, including contributing to the dossier. Person Specification The person specification(s) for this post is attached as Appendix A. Informal Discussions For an informal discussion please contact Professor Lee Shepstone (e:mail: l.shepstone@uea.ac.uk or phone: ).

4 Norwich Clinical Trials Unit Norwich Clinical Trials Unit (NCTU) has been established by UEA and Norfolk and Norwich University Hospitals (NNUH) to provide an effective platform for the conduct of high quality clinical trials and to provide a forum for training and methodological advancement in trial design, conduct and analysis. This includes developing funding applications, trial design, management, quality assurance, analysis and reporting. The NCTU is led by the Director, Professor Ann Marie Swart and Associate Directors, Professor Lee Shepstone (Professor of Statistics) and Dr Garry Barton (Reader in Health Economics). The vision is to establish an internationally recognised clinical trials unit to conduct important trials across a broad range of clinical disciplines which influence clinical and research practice and are published in high impact journals, thus enhancing the international research reputation of Norwich Research Park (NRP). Norwich CTU is a key asset for translational research by Norwich Research Park Partners made up of the UEA, NNUH, John Innes Centre, Institute of Food Research, Sainsbury Laboratory and the Genome Analysis Centre. These institutions form an extensive bioscience community which is identifying new ways to improve human health. Norwich CTU is undergoing an expansion, in recognition of its importance to reliably evaluate new treatments and take advantage of a growing pipeline of investigative compounds that can be taken from early to late stage using technology, development and trials expertise across the Norwich Research Park Norwich CTU is fully registered as a UK Clinical Research Collaboration trials unit and receives National Institute for Health Research (NIHR) CTU support funding to help the CTU in developing and supporting NIHR trials. Research Design Service The Research Design Service (RDS) remit is to offer high quality advice and support on research design and methodology to researchers making funding applications and doing research within the health research system. The East of England RDS (see has close links with the Norwich CTU. Dr. Garry Barton (Deputy Director of the East of England RDS) and Professor Lee Shepstone (Statistics lead for the East of England RDS) are both Associate Directors of the Norwich CTU, and Dr Jean Craig (Research advisor) is a member of the Norwich CTU management group.

5 The Faculty of Medicine and Health Sciences (FMH) The Faculty of Medicine and Health Sciences is led by the Executive Dean of Faculty, Professor Ian Harvey, working closely with the Heads of School, and the Associate Deans who share responsibility for the areas of Research; Enterprise and Engagement; Learning and Teaching; Admissions; and Postgraduate Research. These senior academics, together with the Director of University Services, the Faculty Human Resources Manager, and the Faculty Finance Manager, form the Faculty Executive. Teaching is organised through the Faculty s two Schools of study, comprising Health Sciences (HSC) and Norwich Medical School (MED), assisted by a Centre for Inter-professional Practice (CIPP). The Faculty also has strong research links with the Norwich Research Park, comprising the Institute of Food Research (IFR), the John Innes Centre (JIC), and the Norfolk and Norwich University Hospital NHS Foundation Trust, see The post-holder will have an appropriate level of research skills, experience and track record in an area that complements the existing skill mix of the team, in order to support the research strategy within the Faculty. Researchers within the Faculty of Medicine and Health Sciences benefit from: a dedicated Associate Dean of Research; appropriate support in all aspects of their research activity; a well-resourced Research Office to support the process of submitting research grant applications; our collaborative approach and close links with practitioners in a wide range of clinical specialities across the region; strong collaboration within the Faculty of Medicine and Health Sciences and across other professional schools and academic disciplines across the University; exposure to expertise in both qualitative and quantitative paradigms of research, and support for appropriate conference and course attendance. The Norwich Medical School Interim Head of School: Professor Nigel Norris The Medical School is now in its thirteenth year and has appointed a successor to the recent Head of School/Dean, Professor David Crossman. Professor Michael Frenneaux joins the Medical School as the new Head of School/Dean in January The Medical School at UEA was established in 2001 and has over 160 members of academic, research and support staff - and a large number of active NHS secondees and honorary appointees - from a wide range of

6 disciplines (including medical specialties, biological sciences and a range of social and statistical disciplines, including health economics, psychology, epidemiology, and medical statistics). The School has grown with a current entry each year of 168 students. Its first students graduated in 2007 and in 2008 the Medical degree programme came sixth out of the 32 UK medical schools in the national Student Satisfaction Survey. The School promotes interdisciplinary teaching and learning and offers a wide range of programmes including: an innovative and highly integrated five-year MB/BS programme commenced in 2002 with an initial intake of 110 students per year, now 168 students per year one year research intensive Masters degree in Health Research (MRes) supplying research experience and transferrable skills the modular MSc programme in Health Sciences for the continuing professional development of a wide range of health care professionals (currently attracting over 100 registered students including GPs and junior hospital doctors) a Masters in Clinical Education (MClinEd) degree a doctoral programme (ClinPsyD) in clinical psychology (with over 60 postgraduate students on the programme) the degrees of PhD, MPhil and MD, awarded by thesis or by portfolio of published work. There are a growing number of clinical academics in the areas of stroke and ageing; respiratory medicine; gastroenterology; clinical pharmacology; cardiology; surgery; primary care; public health and epidemiology; rheumatology; diabetes and orthopaedics. The Medical School has recently received an allocation of Walport academic training posts amounting to four new Academic Clinical Fellowships and two new clinical lectureships for each of the next three years. There is particular strength within the Medical School in epidemiology, statistics and health economics and exciting possibilities for appointees to develop clinical trials within the Clinical Trials Unit as well as experimental medicine within the seven bed Clinical Research Facility (CRF). The School is committed to appropriate multi-disciplinary working and the post holder will find excellent on-going collaborations across a wide range of disciplines. The School of Health Sciences Head of School: Professor Valerie Lattimer On 1st August 2014, the Schools of Nursing Sciences and Rehabilitation Sciences at UEA came together to create a new School of Health Sciences. The School s purpose is to resolve health challenges through the advancement of knowledge and interdisciplinary working. This innovative development has built on the strong reputation of the two Schools and creates an outstanding learning environment for students; fostering cutting edge

7 research and offering opportunities for real innovation in enterprise development. The School of Health Sciences encompasses a family of interrelated disciplines; midwifery, all fields of nursing, operating department practice, paramedic science, physiotherapy, occupational therapy and speech and language therapy. Our research is focussed on developing solutions to future global health challenges as a consequence of our life style choices (e.g. obesity, diabetes); living longer with long term conditions and the need for systems, services and training models to adapt to different health care needs in the future. We have a clear vision and strategy to be a leading international academic force in our field, improving the quality of healthcare through our research and education. The School s academic structure is designed to secure the delivery of our strategy. Staff belong to one of three health challenge units which drive innovation in research, teaching and learning in three theme areas: reforming health systems; promoting family and community health and living well with long term conditions. The groups foster a collaborative ethos and serve as an academic home community for those with related interests from a variety of professional backgrounds. We support our academic staff to actively engage in practice and provide opportunities to extend personal development linked to performance. As a School community we are committed to sustained engagement with staff, students, service users and carers and we aim to be in tune with the priorities and requirements of our NHS partners and other providers at a time of considerable change and resource constraint in the wider economy. We have developed excellent partnership working with other HEIs, commissioners and health care providers in the region and work closely with clinical colleagues to maintain and develop clinical experience for students, as well as providing a mechanism for incorporating their role as mentors and clinical educators into lifelong learning. We currently have over 1300 undergraduate, pre-registration students and around 1200 post registration and postgraduate students taking a variety of modules and courses, including our flagship NIHR Masters in Clinical Research. The success of the School is reflected by the popularity of its programmes and a number of measures of esteem. The School is ranked 5th for nursing and midwifery and 7th for health professions in the Guardian University Guide (2015) and has recently climbed four places to 8th place for nursing in the Complete University Guide (2015).

8 GENERAL Salary Salary will be dependent on knowledge, skills and experience of the successful candidate at either 24,775 to 30,434 per annum on Grade 6, or 31,342 to 37,394 per annum on Grade 7, on the single salary spine. The normal expectation is that the starting salary will be at the minimum of the advertised salary scale. The appointment will be in accordance with the terms and conditions for Research and Analogous staff. The candidate to whom an appointment is offered will receive a full statement of the terms and conditions of appointment. Starting date The post is available immediately on a full-time basis, until November Terms and Conditions of appointment Full details of terms and conditions of employment for Research & Analogous Staff will be made available to the candidate to whom the appointment is offered, but attention is drawn at this stage to the following conditions: Joint Venture As a member of the Norwich Medical School, appointees will be accountable to the University as employer via the Head of School (MED) and the Joint Venture Management Board (of which both the Head of School (MED) and the Dean of the Faculty of Medicine and Health Sciences are members, along with the Chief Executives of all NHS partners). Annual Leave Entitlement There is an annual holiday entitlement of six weeks plus statutory (8 days) and customary (6 days) holidays. Superannuation The post is superannuable under the Universities Superannuation Scheme or (for staff already in membership) the NHS pension scheme whilst a member of the Norwich Medical School. This appointment will be subject to: Proof of Qualifications The person specification for this post lists qualifications that are essential and/or desirable and you may hold some or all of these qualifications. Please

9 note that if you are offered the post you will be asked to provide original certificates of these educational and professional qualifications. Please DO NOT provide these with your application. Entitlement to Work in the United Kingdom If you are shortlisted for interview you will be asked to bring to interview original documentary evidence of permission to work in the UK. Candidates invited to interview will be provided with a list of appropriate documents that can be provided as evidence. Please DO NOT provide this with your application. Due to the nature of this role and the level of qualifications required, please note that immigration legislation allows the University to apply for a sponsorship certificate for this post. Where appropriate, the University will apply for a sponsorship certificate from the UK Border Agency on behalf of the candidate offered employment. The individual will be required to supply original documents and certificates to support this application. Workers from outside of the EU who do not have current residency status within the UK and will require entry clearance or leave to remain approval from the Borders Agency should familiarise themselves with Tier 2 (General) of the Points Based System operated by the Home Office. Details are available at Occupational Health Assessment Appointment will be subject to a satisfactory Occupational Health Assessment to be carried out by the University s Occupational Health Service. APPLICATION AND RECRUITMENT PROCESS Your completed application form should quote reference code RA1153 and be returned by no later than 12 noon on 4 February 2015 in one of the following ways: accessed via the relevant vacancy details at then downloaded in Word format to be completed electronically then saved and sent as an attachment to hr@uea.ac.uk or accessed via the relevant vacancy details from then downloaded in Word format to be completed electronically, then printed and posted to the Human Resources Division, University of East Anglia, Norwich, NR4 7TJ, or accessed via the relevant vacancy details from and downloaded in PDF format and

10 printed, to be completed by hand and returned by post to the Human Resources Division at the address shown above or forms received by post from the Human Resources Division should be completed by hand or typed and returned by post to the above address. Postal applications will not be acknowledged unless a stamped addressed envelope/postcard is supplied. For paper submissions please ensure you add the correct postage to your application pack as failure to do so will considerably delay receipt by this office and may jeopardise your application for this post. Please note that applications received after the closing date will not normally be accepted. If you are submitting an application by post immediately prior to the closing date please contact the Human Resources Division on to let us know that your application has been posted, and if possible also send a copy by fax to or by to hr@uea.ac.uk in order that we receive these by the closing date. Please note that feedback will not normally be provided to those applicants who are not shortlisted for this post. Applicants for posts with a reference code beginning RA must ensure they submit a covering letter and three paper copies of their curriculum vitae, or one copy if submitting the application by , along with their completed application form. Equal Opportunities Monitoring Form Please note that an Equal Opportunities Monitoring Form must be completed and returned with ALL applications, whether submitted by post or by . If submitted by , the Equal Opportunities Monitoring Form must be sent as a separate document/attachment to the Application Form. The Equal Opportunities Monitoring Form will be detached from the received application before short-listing takes place and will not form any part of either the short-listing or decision making process. Referees In naming referees in your application, you are requested to give only those who can immediately be approached and one of these must be your current employer, or if not employed your most recent employer. Interviews It is anticipated that interviews will take place late February 2015 and candidates who have not heard by 20 February 2015 should assume their application has been unsuccessful. Successful shortlisted candidates may be

11 notified of their interview times by telephone and/or and it is therefore essential you include both of these in your application. This document is available in alternative formats e.g. large print, disc and on-line. If you need this document in an alternative format please contact us on , fax , or

12 APPENDIX A PERSON SPECIFICATION CTU STATISTICIAN, GRADE 6 Post title: CTU Statistician (Ref: RA1153) CRITERIA Essential Desirable Education, Experience & Achievements Skills & Knowledge Personal Attributes MSc or PhD in Medical Statistics (or closely related subject). Familiarity with one or more statistical packages (SAS or Stata). Excellent computer skills. Ability to take on some responsibility for the day-to-day management of statistical aspects of a project running of projects. Practical experience in clinical trials or related work. Experience of managing a discrete analysis project largely unsupervised. Presenting results of own work to peers and colleagues. Contributing to peerreviewed publications in health-related research. Experience of providing advice on statistical aspects of study design to health care professionals. Experience of collaboration in successful research grant applications. Ability to explain statistical techniques to health care professionals. Good oral and written communication skills. Ability to prioritise tasks and work to deadlines. Meticulous attention to detail.

13 Flexible approach to work. Ability to work in a multidisciplinary team. Special Circumstances Willing and able to travel to other parts of the East of England region, London and able to travel abroad for conferences.

14 PERSON SPECIFICATION CTU STATISTICIAN, GRADE 7 Post title: CTU Statistician (Ref: RA1153) CRITERIA Essential Desirable Education, Experience & Achievements Skills & Knowledge Personal Attributes MSc or PhD in Medical Statistics (or closely related subject) Practical experience in clinical trials or related work. Experience of managing a discrete analysis project largely unsupervised. Presenting results of own work to peers and colleagues. Contributing to peer-reviewed publications in health-related research. Familiarity with one or more statistical packages (SAS or Stata). Excellent computer skills. Familiarity with research governance and GCP requirements for analysis of clinical trials. Ability to take on responsibility for the day-to-day management of statistical aspects of a project. Experience of providing advice on statistical aspects of study design to health care professionals. Experience of collaboration in successful research grant applications. Ability to explain statistical techniques to health care professionals. Special Circumstances Good oral and written communication skills. Ability to prioritise tasks and work to deadlines. Meticulous attention to detail. Flexible approach to work. Ability to work in a multidisciplinary team. Willing and able to travel to other parts of the East of England region, London and able to travel abroad for conferences.