You will support the clinical trials and other projects undertaken within the LCTU and under the guidance of the senior statisticians, will collaborate with senior researchers in planning new projects including grant applications and trial protocols. Provision of statistical advice and statistical analyses of trial data for investigators in compliance with legislative frameworks in the LCTU. To collaborate, under the guidance of senior statisticians, on developing trial grant applications and the development of trial protocols, particularly to Cancer Research UK, Leukaemia Research Fund and the National Institute for Health Research and the development of trial protocols
You should have Degree in statistics, medical statistics or equivalent qualification or relevant professional experience. You must be able to work independently as well as part of a team, and have effective interpersonal skills
Faculty: Health and Life Sciences, Institute of Translational Medicine, Department of Molecular and Clinical Cancer Medicine Location: University Campus Grade: 6 Salary: Depending on qualifications and experience Range: £28,098 - £32,548 pa Tenure: 12 months in the first instance Hours of work: Full-Time Closing Date: 7 May 2018 Interview Date: To be confirmed Informal enquiries to Dr Richard Jackson on 0151 795 5288 email: R.J.Jackson@liverpool.ac.uk STATISTICIAN IN MEDICAL STATISTICS Job Ref: 009104 The Post FACULTY OF HEALTH AND LIFE SCIENCES INSTITUTE OF TRANSLATIONAL MEDICINE DEPARTMENT OF MOLECULAR AND CLINICAL CANCER MEDICINE CANCER RESEARCH UK LIVERPOOL CANCER TRIALS UNIT (LCTU) STATISTICIAN IN MEDICAL STATISTICS BACKGROUND The Cancer Research UK Liverpool Cancer Trials Unit (LCTU) is based within the Department of Molecular and Clinical Cancer Medicine, University of Liverpool. The LCTU is responsible for conducting large Phase III, Phase II and Phase I cancers trials. The portfolio of clinical trials involves several major tumour areas including, Pancreatic, Uveal Melanoma, Head and Neck Cancers and Lymphoma and Haematological Malignancies with plans for expansion into further areas. The LCTU is established with core funding from Cancer Research UK and is supported by the University of Liverpool and the three major NHS trusts responsible for delivering the bulk of cancer care in the Liverpool City region: the Royal Liverpool University Hospital, Aintree University Hospitals NHS Foundation Trust and Clatterbridge Cancer Centre. The Director of the LCTU is Professor Paula Ghaneh. The Liverpool Cancer Trials Unit also oversees the Liverpool Experimental Drug Development Unit (LEDDU) and the Northwest Surgical trail Unit (NWSTC) responsible for Phase I/II trials and surgical trial respectively. Both the Liverpool Cancer Trials Unit and the LEDDU are key components of the Cancer Research UK Centre. Finally the LCTU is also part of the Liverpool Trials Collaborative which under the leadership of Professor Tom Walley and oversight by the University of Liverpool Clinical Trial Oversight Committee (CTOC) runs non-cancer NIHR/HTA/RfPB funded trials. The Liverpool Trials Collaborative is a registered UKCRC Registered CTU Network consisting of the LCTU and the Clinical Trials Research Centres also hosted within the University. The aim of the LCTU is to conduct and provide support for clinical trials undertaken nationally and internationally. The LCTU provides advice and support on all aspects of trial design and management, including but not limited to: • Grant Applications. • Project Costings. • Protocol Development. • Case Report Form Development and Data Management. • Regulatory Authority and Research Ethics Committee Submissions. • Design and Analysis of clinical trials. • IT Infrastructure. • Pharmacovigilance. • Oversight Committee Management (Data Monitoring and Trial Steering Committees). • Manuscripts for publication. • Randomisation Services (including central telephone randomisation). • Ongoing management of trials. • Monitoring (central and on-site). • Research Site Management. ROLE The purpose of this statistics post is to support clinical trials and studies in the Cancer Research UK Liverpool Cancer Trials Unit. The post will be operationally based in the LCTU. Management of this post is by Dr. Richard Jackson, Senior Statistician. The job descriptions are by no means exhaustive and are intended as a guide to the post holder. It may be altered in the light of working experience, at the discretion of and in liaison with the Senior Statistician / Director of Statistics. RANGE OF DUTIES Provision of statistical advice and statistical analyses of trial data for investigators in compliance with legislative frameworks in the LCTU (EU Clinical Trials Directive; Research Governance framework for Health and Social Care; Data Protection Act etc.). To collaborate, under the guidance of senior statisticians, on developing trial grant applications and the development of trial protocols, particularly to Cancer Research UK, Leukaemia Research Fund and the National Institute for Health Research and the development of trial protocols. To contribute, under the guidance of Senior Statisticians, to the provision of statistical advice on applications for Clinical Trials Authorisation and Research Ethics Committee (REC) approval. To contribute, under the guidance of senior statisticians, to a risk-based assessment of trials within the LCTU and the Liverpool CR-UK Centre to determine the nature and extent of monitoring required. Collaborate with trial managers and computing staff on form design, database design and management, and trial monitoring. Preparation and presentation of statistical reports presented to Trial Steering Committees and Data Monitoring and Ethics Committees for trials managed through the LCTU. To work with investigators in writing papers for publication in medical journals. To keep up to date with current methodological research related to trial design, monitoring and analysis. To collaborate, under the guidance of senior statisticians, in relevant research related to trial design and analysis. To contribute to, under the guidance of senior statisticians, the development and implementation of systems for monitoring progress of trials against timelines and milestones. To work with senior statisticians in the LCTU on the development of systems to ensure compliance with the principles of Good Clinical Practice (GCP) as part of the wider Liverpool CR-UK Centre agenda. Contribute to the preparation of Standard Operating Procedures (SOPs). WORKING RELATIONSHIPS You will collaborate with clinicians, statisticians and research staff within the LCTU and other research departments in the University to develop specific trials projects. You will interact closely with other LCTU statisticians, clinical trial co-ordinators and data managers and IT staff (network and database developers) to ensure full statistical support on grant applications, trial conduct (such as interim analyses), and final analysis. External collaboration could be with investigators from other Universities, staff from National Cancer Research Institute (NCRI) accredited Trials Centres, clinical and research staff at collaborating hospitals, National Cancer Research Network staff, members of Trial Management Groups, and independent Data Monitoring Committees and Trial Steering Committees. You will be encouraged to interact with clinicians and clinical groups nationally and internationally, in particular the NRCI Clinical Studies Groups, whose members choose to conduct their study from the LCTU. PROFESSIONAL ACCOUNTABILITIES You will be expected to know of or become familiar with the following: The EU Clinical Trials Directive (2001/20/EC) (enacted in the UK by The Medicines for Human Use (Clinical Trials) Regulations 2004 SI 2004/1031 and Amendments) and other applicable laws and regulations. International Conference on Harmonisation Good Clinical Practice (ICH GCP) and The NHS Research Governance Framework. The Data Protection Act 1998 and the Computer Misuse Act 1990. University of Liverpool and Liverpool CR-UK Centre policies and procedures. Person Specification ESSENTIAL CRITERIA DESIRABLE CRITERIA (Identified from - Application form, CV, Supporting Statement, Interview, References) EXPERIENCE 1. Knowledge of clinical trials, design and statistical analysis. Experience in the design, monitoring and analysis of randomised clinical trials. 2. Experience of working with Data Monitoring and Ethics Committees and/or Trials Steering Committees. 3. Research of relevance to clinical trials. 4. Experience and knowledge of working within clinical trial legislative frameworks. EDUCATION, QUALIFICATIONS AND TRAINING 1. Degree in statistics, medical statistics or equivalent qualification or relevant professional experience SKILLS, GENERAL AND SPECIAL KNOWLEDGE 1. Good statistical programming skills. Knowledge of the conduct of clinical research to GCP. 2. Grasp of statistics applicable to clinical investigations. 3. Written and presentational communication skills. 4. Organisational skills. PERSONAL ATTRIBUTES AND CIRCUMSTANCES 1. Attention to detail. 2. Ability to work independently and as part of a team. 3. Able to prioritise and time manage work activities, work to deadlines and demonstrate initiative. A World Class University The University of Liverpool is one of the UK’s leading research institutions with an annual turnover of £480 million, including £133 million for research. Liverpool is ranked in the top 1% of higher education institutions worldwide and is a member of the prestigious Russell Group, comprising the leading research universities in the UK. As an international institution, we have 31,000 students and 195,000 alumni in 200 countries. Our global focus has led us to establish a university in the World Heritage city of Suzhou near Shanghai, in partnership with Xi’an Jiaotong University - a top 10 university in China. Liverpool is popular with students from all over the world, with 7,700 international students from all over the world studying at the University. We are also the largest provider of 100% online postgraduate degree courses in Europe with some 10,000 students studying for University of Liverpool degrees around the world. Associated with no fewer than nine Nobel Laureates, we are recognised for our high-quality teaching and research. In the UK Government’s most recent research assessment exercise, a total of 81% of the University’s research staff were ranked in the highest categories of 4* (world-leading) and 3* (internationally excellent) for their research. Addressing some of the world’s toughest challenges, our research is helping to transform lives. Here you can work with us to conduct research that has a positive impact on people and the planet, to share ideas with peers, with business and beyond, to further widen your world view within our international network of academic partners and to prepare to be a true global citizen. Here at the University, we can help you to make a real difference to the wider world. The University continues to strengthen key aspects of the student experience, investing £600 million in its teaching, research and residential estate over a 10-year period including £250 million in high quality accommodation and £350 million in the city centre campus and at the Veterinary Science site at Leahurst on the Wirral. Life Changing, World Shaping The City of Liverpool As the seventh largest city in the UK, Liverpool is diverse, energetic and exciting. Built on an illustrious heritage that stretches back 800 years, Liverpool has a global reputation for sport, music, architecture and culture. Today the city is enjoying a resurgence, driven by its designation as European Capital of Culture in 2008. Record levels of inward investment have transformed the city. The regeneration of Liverpool City Centre has been spearheaded by the £1 billion Liverpool One project - one of Europe's biggest shopping/mixed-use schemes, which has positioned the city as one of the UK's top five retail destinations. The successful European Capital of Culture experience in 2008 has been followed by the designation of Liverpool's stunning waterfront as a UNESCO World Heritage Site and massive investment in new cultural and leisure attractions, including Albert Dock. Liverpool is a major cultural hub in the UK. In fact, there are more museums, theatres, and galleries in Merseyside than in any other region outside London. Liverpool Philharmonic Hall, home to the Royal Liverpool Philharmonic Orchestra, one of Europe’s leading orchestras, is the classical counterpoint to the city’s many contemporary music venues and the visually stunning Echo Arena. Home to two of Europe’s most famous football teams - Liverpool FC and Everton FC- the city’s achievements in sport are internationally recognised. Aintree Racecourse, home of the Grand National, and two internationally acclaimed golf courses at Royal Birkdale & Royal Liverpool in Hoylake are on the doorstep. Compared to many other UK cities Liverpool has less congestion, is closer to countryside, has more parks, has more cultural and recreational opportunities, better schools and more accessible transport. Liverpool is uniquely situated 1 hour from Manchester, 3 hours from London by train and the city’s Liverpool John Lennon Airport (one of the Europe's fastest growing airports) connects to more than 650 world-wide destinations. For more information on the city of Liverpool, visit: www.itsliverpool.com General Information Asylum & Immigration The University will comply with the Immigration, Asylum and Nationality Act 2006, which requires all employees to provide documentary evidence of their legal right to work in this country prior to commencing employment. Candidates will be required to bring their passport (and visa if applicable) to interview so that it can be copied and verified by a member of the Selection Panel. For support staff vacancies, it is not likely that the University would be able to make a successful application for a Certificate of Sponsorship. For this type of post, it is unlikely that we would be able to appoint an individual who is not currently eligible to work in the UK. Further information about Certificate of Sponsorship and eligibility to work in the UK, can be found at: www.ukba.homeoffice.gov.uk/employers/points National Insurance Number All employed individuals must possess a UK National Insurance Number. Further information and how to apply for a unique National Insurance Number can be found at: https://www.gov.uk/apply-national-insurance-number Diversity and Equality The University of Liverpool is committed to diversity and equality of opportunity. All employees and applicants for jobs will be considered on their abilities and will not be discriminated against on the grounds of age, caring responsibilities, colour, disability, employment status, gender, gender identity, marital status, nationality, race or ethnic origin, religion or belief, sexual orientation, socio-economic status or any other irrelevant distinction. Training is available to support career progression within the University. Two Ticks Disability: Guaranteed Interview Scheme (GIS) The University of Liverpool is committed to the employment of disabled people, and as part of our commitment, we guarantee to interview all disabled applicants who meet the essential criteria for a post and consider them on their abilities. If your disability prevents you completing the application form by the specified closing date, or when the vacancy closes early, due to a high volume of applications, please call the Recruitment Team to discuss alternative arrangements. http://www.liv.ac.uk/working/jobvacancies/guaranteedinterviewscheme/ Volition Programme The University of Liverpool supports the Liverpool Anglican Cathedral Volition Programme. Applicants who have successfully completed the programme and meet the essential criteria for the post will be offered a guaranteed interview. Please note that individuals will be confirmed through the Volition Programme directly. http://www.liv.ac.uk/working/jobvacancies/volitionprogramme/ GiveGetGo Volunteer Programme Applicants who have successfully completed the GiveGetGo Volunteer Programme at the University in Partnership with the Transform Lives Company who meet the essential criteria for the post will be offered a guaranteed interview. Please note that individuals will be confirmed through the GiveGetGo Volunteer Programme directly. https://www.liverpool.ac.uk/working/jobvacancies/givegetgo/ Accessibility If you require copies of documentation in alternative formats, for example, large print or Braille, please contact firstname.lastname@example.org or telephone 0151 794 6771. If you have any other requirements which will help you access the application or interview process or employment opportunities at the University of Liverpool, please let us know by contacting email@example.com or telephone 0151 794 6771. Pension The Occupational Pension Scheme associated with this appointment is the University of Liverpool Pension Fund (ULPF). You are encouraged to familiarise yourself with the full particulars of the scheme which can be found here.
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