The post holder will provide statistical advice and support in the design, conduct and analysis of clinical studies and allied research within the Birmingham Clinical Trials Unit (BCTU).
Scope of the Role
The post holder will provide statistical advice and support to BCTU's clinical trial, diagnostic and test evaluation research programme that addresses a wide and interesting range of medical problems of practical relevance to patients, carers and health care providers. The post holder will work alongside a number of statisticians supporting studies within BCTU, under the mentorship of a senior statistician. The Unit is currently running studies in coloproctology, neurosciences, obstetrics and gynaecology, primary care, renal disease, surgery, burns, trauma and critical care.
Main Duties and Responsibilities
- Provide statistical advice on the design of clinical trials, diagnostic and test evaluation studies, under the mentorship of a senior member of the Statistics Team.
- Contribute to the writing of grant applications, under the mentorship of a senior member of the Statistics Team.
- Contribute to the writing of study protocols and the development of data collection forms, under the mentorship of a senior member of the Statistics Team.
- Liaise with Programmers and Trial Managers in the development and testing of data management systems.
- Determine appropriate statistical analysis of study data and write statistical analysis plans, under the mentorship of a senior member of the Statistics team.
- Undertake statistical analysis to assist Trial Managers in the running of studies, and monitor data quality of on-going studies.
- Undertake appropriate statistical analysis of study data and prepare reports for Data Monitoring and Steering Committees, and contribute to presentations and publications, under the mentorship of a senior member of the Statistics Team.
- Assist in the mentorship and supervision of junior members of the Statistics Team.
- Contribute to the writing of Standard Operating Procedures for the Trials Unit.
- Provide statistical advice and/or analysis of data as part of the Unit’s support and advice service.
- Lecture on basic statistics and clinical trial methodology and provide in-house staff training.
- Undertake statistical methodological research relevant to the studies being undertaken within BCTU.
- 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, 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.
- MSc or PhD in Statistics, or a relevant higher degree with a high mathematics and statistics content.
- Experience (at least 2 years) of working as an applied medical statistician.
- Experience in medical statistics and clinical trials.
- Knowledge of diagnostic and test evaluation studies.
- Experience of applying statistical techniques e.g. linear, logistic and Cox regression, analysis of variance, repeated measures, survival analysis.
- Experience in statistical analysis packages and programming, preferably in SAS and/or STATA
- Experience of computer-based database management and data extraction/ reporting techniques (preferably Access/SQL).
- Knowledge of the protected characteristics of the Equality Act 2010, and how to actively ensure in day to day activity in own area that those with protected characteristics are treated equally and fairly.
- Ability to work well both on own initiative and as part of a team.
- Good inter-personal, verbal and written communication skills.
- Meticulous attention to detail and high levels of accuracy.
- Aptitude for analysis which is real life and problem driven
- Interest in the application of statistical techniques for medical problems.
- Willingness to learn new techniques.
- Ability to impart statistical concepts to non-statisticians.
This post provides an excellent opportunity for a medical statistician to develop their experience and expertise within a leading academic trials unit undertaking methodologically challenging research. The post holder will provide statistical advice and support to BCTU's clinical trial, diagnostic and test evaluation research programme that addresses a wide and interesting range of medical problems of practical relevance to patients, carers and health care providers.
The post holder will work alongside senior members of the Statistics team supporting studies within BCTU, but should be capable of working with minimal supervision as a study statistician within a fairly short time of appointment.
Statisticians play a central role in the Unit, actively liaising with clinical investigators, contributing to the design and conduct of clinical trials, being responsible for interim and final analysis of clinical trial data and having a key role in the presentation and publication of results. As academic members of the University, statisticians contribute to teaching at undergraduate and postgraduate level.
Statisticians are encouraged to take an interest in the medical areas, and understand the clinical issues and problems relating to the disease areas in which they work. This enables them to contribute to disease-specific research at a national and international level.
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.
Internal and external relationships
As part of the Statistics team, the post holder will work with Senior Statisticians in the team advising clinical investigators and other researchers on the feasibility, design and analysis of proposed and current studies, and sit on project management groups.
The post holder will be required to contribute to decisions on the appropriate methodology to apply to research questions and discuss this with researchers.
There will be in-house teaching commitments and occasional contributions to postgraduate and continuing professional development courses run by the School and other departments.
For informal enquiries please contact Mrs Natalie Rowland (née Ives)
Reader in Clinical Trials, Statistics Team Leader firstname.lastname@example.org
The University is committed to safeguarding and we promote safe recruitment practice, therefore all associated pre-employment checks will be undertaken before any appointment is confirmed.
Valuing excellence, sustaining investment
We value diversity at The University of Birmingham and welcome applications from all sections of the community’