Description Position Details Cancer Research UK Clinical Trials Unit, School of Medical Sciences, College of Medicine and Health Location: University of Birmingham, Edgbaston, Birmingham UK Full time starting salary is normally in the range £46,485 to £55,295 with potential progression once in post to £62,098 Grade: 8 Full Time, Fixed Term contract up to August 2029 Closing date: 10th March 2025 UK and International travel may be required for this role Our offer to you People are at the heart of what we are and do. The University of Birmingham is proud to have been a part of the City of Birmingham and the wider region for over 100 years, and we are equally proud to be recognised as a leading global university. We want to attract talented people from across the city and beyond, support them to succeed, and celebrate their success. We are committed to helping the people who work here to develop through our sector-leading Birmingham Professional programme which provides all professional services staff with development opportunities and the encouragement to reach their full potential. With almost 5,000 professional services jobs in a wide-range of functions in Edgbaston and in our campus in Dubai, there are plenty of opportunities for you to be able to develop your career at the University. We believe there is no such thing as a typical member of staff and that diversity is a source of strength that underpins the exchange of ideas, innovation, and debate. We warmly welcome people from all backgrounds and are committed to fostering an inclusive environment where diversity is at the heart of who and what we are, and how we work. Supporting our people to achieve a healthy work/life balance is important both to our employees and to the success of the University and, depending on the role, we offer a variety of flexible working arrangements. We therefore welcome discussions on all forms of flexible working. In addition, you will receive a generous package of benefits including 40 days paid holiday a year, one paid day a year for volunteering, occupational sick pay, and a pension scheme. We also have three high quality subsidised day nurseries. The University is situated in leafy Edgbaston and there are excellent transport links to our beautiful campus, including main bus routes and a train station on site. On campus we have a state-of-the-art sports centre with pool, shops, places to eat and drink, our own art gallery, museum and botanical gardens. Find out more about the benefits of working for the University of Birmingham Background This is an exciting opportunity to join one of the largest UK Clinical Research Collaboration (UKCRC) registered clinical trials units in the country. The Cancer Research UK Clinical Trials Unit (CRCTU) is a Department within the School of Medical Sciences at the University of Birmingham. The CRCTU employs a multidisciplinary team of around 200 staff including statisticians, trial management staff, research nurses, monitors, programmers, administrators and IT staff. It specialises in running early and late phase clinical trials in adults and children. Alongside trials portfolios in a broad range of adult solid cancers and haemato-oncology, CRCTU is the national lead for prestigious programmes of children’s cancer and leukaemia trials. The unit also includes two trials teams dedicated to non-cancer trials: the Diagnostics, Drugs, Devices and Biomarkers team (D3B), running mainly early-phase trials, and the Inflammation, Advanced and Cellular Therapy (I-ACT) team, specialising in trials in rheumatology and advanced therapies. Recently, CRCTU has been awarded funding from LifeArc, as part of a consortium with Newcastle University and Queen’s University Belfast, to establish a new trials team specialising in trials in rare diseases (known as Rare Diseases Trials Acceleration Programme (RD-TAP)). The post holder will work primarily with this new team to establish a portfolio of trials in rare diseases. CRCTU also hosts a “node” of the Rare Disease Research UK platform, called CAPTIVATE, which is dedicated to methodological research for rare disease trials. The post holder will work closely with this group, and with colleagues in Newcastle University, to develop and implement innovative trial designs. More information on CRCTU can be found at https://www.birmingham.ac.uk/research/crctu/index.aspx Role Summary As a member of the Biostatistics team the post holder will play a central role in Cancer Research UK Clinical Trials Unit’s (CRCTU) research and educational activities. They will actively liaise with clinical investigators, contribute to the design and conduct of clinical trials, be responsible for interim and final analysis of clinical trial data and have a key role in the presentation and publication of results. As academic members of the University, Biostatisticians contribute to teaching at undergraduate and postgraduate level. The post holder will contribute to the design and analysis of the CRCTU’s clinical trials, in addition to contributing to methodological and trial-related clinical research. The post holder will work within a large team of biostatisticians, specialising in specific disease sites, trial phases and methodological areas. They will have the opportunity to contribute to trial portfolios in a variety of solid and haematological cancers and in non-cancer, in both adult and paediatric populations. This post provides an excellent opportunity for a bright, ambitious biostatistician to apply their experience and expertise within a leading academic trials unit undertaking methodologically challenging research. Hybrid working is possible in line with both CRCTU and University of Birmingham policies. Main Duties Provide expert statistical advice for the design of clinical trials and related studies, and develop clinical trial protocols in collaboration with Clinical Investigators, internally and externally to the Unit. Take overall responsibility for the analysis of clinical trial data, preparing and presenting reports for Data Monitoring and Steering Committees and contributing to presentations and publications of clinical trial results. Collaborate with Clinical Investigators in the submission of grant applications. Supervise, in collaboration with Programmers and Trial Coordinators, the setting up of a randomisation process and development of data collections forms and databases for trials. Determine appropriate statistical analysis and write statistical analysis plans for clinical trial data, drawing upon novel methodology where appropriate, and provide guidance to other members of the Biostatistics Team in their analysis plans as required. Supervise the statistical input to assist Trial Coordinators in the running of on-going trials and monitoring of data quality. Collaborate on relevant projects with researchers in other Schools within the University of Birmingham and manage the contributions to such projects from members of the Biostatistics Team. Take responsibility for statistical inputs to the Standard Operating Procedures for the Trials Unit. Take the lead in statistical methodological research projects relevant to clinical trials and associated translational research, including collaboration with researchers at other institutions and supervision of other members of the Biostatistics Team in methodological research. Project-manage the statistical contributions to trials, supervising the analysis undertaken by other members of the Biostatistics team. Provide supervision and mentorship for more junior staff. Take overall responsibility for the statistical contributions to publications of clinical papers, taking the lead when appropriate, and take the overall lead on statistical papers. Present clinical trial results and methodological research at internal and external seminars and national and international conferences. Provide expert statistical guidance to external bodies such as Editorial Boards and Grant Funders. Represent the CRCTU at internal and external clinical and scientific meetings. Lecture on statistics and clinical trial methodology, marking and examining assessments where appropriate and provide in-house staff training. Provide mentorship and supervision for MSc and PhD research students. Liaise with pharmaceutical companies in relation to trials that they support. The post holder will support the delivery of clinical research in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation (including, but not limited to, the Medicines for Human Use Clinical Trials Regulations, Data Protection Act 1998, Human Tissue Act), the Research Governance Framework for Health and Social Care, Caldicott principals, and applicable NHS Trust and University policies and procedures, (including, but not limited to the University’s Data Protection Policy, Information Security Policy and Code of Practice for Research) in order to protect the research subject and the quality of each study. As part of their duties, the post holder will promote equality and value diversity and inclusion through monitoring and evaluation and actively challenging unacceptable behaviour. Pursuit of post-graduate qualifications or personal research interests is encouraged, providing the work is agreed in advance, is of sufficient merit and time is available such that trial work would not suffer. Required Knowledge, Skills, Qualifications, Experience The individual suitable for this post would have experience that is relevant to the design and analysis of clinical trials and would be capable of working independently as a statistician on trials. They would be expected to take the statistical lead in one or more key disease areas covered by the CRCTU within a fairly short time of appointment. Qualifications MSc or PhD in Statistics or relevant subject and possess substantial previous experience of working as an applied medical statistician. Experience and knowledge Extensive experience in clinical trials, specifically trial design and writing of protocols and the analysis, reporting and publication of results. Extensive experience of applying and/or developing successful statistical models, techniques and methods, particularly in relation to clinical trial data. Extensive experience and demonstrated success in planning, undertaking and project managing statistical aspects of clinical trial research to deliver high quality results. Knowledge of statistical packages. Experience in communicating statistical concepts to non-statisticians. Experience in writing reports and papers for publication. Experience of championing Equality, Diversity and Inclusion in own work area with and ability to monitor and evaluate the extent to which equality and diversity legislation, policies, procedures are applied as well as the ability to identify issues with the potential to impact on protected groups and take appropriate action. Abilities and skills Ability to lecture and present. Ability to work well both on own initiative and within a team. Evidence of good inter-personal and communication skills. Aptitude to manage and mentor staff. Ability to contribute to the operational management of the biostatistics team. Ability to apply novel trial methodology in real-world settings. Planning and Organising A flexible attitude and an ability to organise work to meet deadlines while handling more than one task at a time is needed. Problem Solving and decision making An ability to make decisions on the appropriate methodology to apply to research questions is required. The post holder will contribute to the CRCTU research strategy through relevant management committees. Internal and External relationships As a key member of the CRCTU, the post holder will represent the Unit externally, providing statistical advice and expertise to the clinical community and sitting on the management groups and steering committees of individual projects. There will be in-house teaching commitments and occasional contributions to postgraduate and continuing professional development courses run by the School and other departments Further particulars can be found here Informal enquiries to Professor Simon Gates, email: S.Gatesbham.ac.uk View our staff values and behaviours here We believe there is no such thing as a 'typical' member of University of Birmingham staff and that diversity in its many forms is a strength that underpins the exchange of ideas, innovation and debate at the heart of University life. We are committed to proactively addressing the barriers experienced by some groups in our community and are proud to hold Athena SWAN, Race Equality Charter and Disability Confident accreditations. We have an Equality Diversity and Inclusion Centre that focuses on continuously improving the University as a fair and inclusive place to work where everyone has the opportunity to succeed. We are also committed to sustainability, which is a key part of our strategy. You can find out more about our work to create a fairer university for everyone on our website .