Faculty of Medicine and Health
School of Medicine
Leeds Institute of Clinical Trials Research
Clinical Trials Research Unit
Medical Statistician / Senior Medical Statistician
Full / Part time – minimum 50%
Fixed-term post for 3 years
The Clinical Trials Research Unit (CTRU) at the University of Leeds is a leader in the field of
clinical trials and was one of the first 26 clinical trials units across the UK to be awarded full
registration status by the UK Clinical Research Collaboration. The Unit conducts national and
international randomised clinical trials in a variety of clinical fields (cancer, cardiovascular disease
and stroke, mental health, obesity, skin, oral health, musculoskeletal disease and care of the
elderly). The CTRU has a strong methodological portfolio associated with clinical trial research.
Our aim is to support the challenge of changing clinical practice for the better and our past results
and current work has already helped to do this – http://ctru.leeds.ac.uk/
An exciting opportunity has arisen for talented and enthusiastic individuals, keen to join a vibrant,
well-established group of statisticians supporting the Unit’s work on clinical trials. Working in a
multidisciplinary team including statisticians, programmers, clinicians, health economists, health
service researchers and trial managers, you will be involved in a wide range of statistical activities,
including preparing grant applications, design, conduct and analysis of clinical trials, general
consulting to and training of health professionals. You will work on internationally renowned trials
designed to answer questions of real importance to clinicians and patients, ultimately improving
disease outcomes and patient care. We are keen to recruit statisticians with an interest in cancer,
cardiovascular, musculoskeletal or skin disease or with experience of surgical or early phase trials.
If you want to make a difference and be part of a successful, highly talented, multi-disciplinary
team, then we want you. All statistical roles offer excellent opportunities for career development
within a well-established statistical team and a chance to further broaden your expertise through
methodological research. Opportunities also exist for PhD registration.
With a postgraduate qualification with a major statistical component, you will have excellent
interpersonal, communication and time management skills and be able to work well within a
multidisciplinary team.
We welcome applications for the Grade 6 post from individuals still to complete their studies.
This post is for a fixed-term period of 36 months, although further funding may be available.
The University of Leeds is committed to providing equal opportunities for all and offers a
range of family friendly policies (http://hr.leeds.ac.uk/homepage/4/policies). The University
is a charter member of Athena SWAN and holds the Bronze award. The School of Medicine
gained the Bronze award in 2013. We are committed to being an inclusive medical school
that values all staff, and we are happy to consider job share applications and requests for
flexible working arrangements from our employees.
University Grade 6 (£25,513 – £30,434), Grade 7 (£31,342 – £37,394) depending on
qualifications and experience
Informal enquiries regarding the post should be directed to Amanda Farrin +44 (0)113 343 1477,
email a.j.farrin@leeds.ac.uk
If you have any specific enquiries about your online application please contact
ctrujobs@leeds.ac.uk +44(0)133 343 1477
Job Ref: MHCTR1011
Job Description
Medical Statistician - University Grade 6
Role Purpose
To assist in the development and implementation of well-planned clinical trials by providing a
comprehensive statistical service for the research projects undertaken by the CTRU. In addition, to
provide general clinical trials and statistical advice to health care professionals.
Details of the Appointment
The post-holder will be accountable to the Divisional Director / Principal Statistician and
responsible to a Principal Statistician / Senior Medical Statistician.
Main Duties and Responsibilities
(All under the direction and close supervision and support of Principal Statistician / Senior
Medical Statistician)
The following list of tasks illustrates the broad range and level of activities; the exact nature of the
post will be tailored to the skills and experience of the successful candidate.
1. Trials-related statistics:
a) Assist in the statistical design and set up of research projects conducted by the CTRU,
including development of the protocol and design of the case report forms and database.
Using sufficiently persuasive arguments with health professionals to ensure that appropriate
statistical advice is accepted.
b) The preparation of analysis plans and the undertaking of appropriate statistical analysis of
the CTRU’s research projects, using appropriate statistical software and in accordance with
the relevant Standard Operating Procedures.
c) Statistical monitoring of research projects conducted by the CTRU, conducting interim
analysis of data and providing advice about trials (both statistical and other trial related
issues e.g. recruitment, funding) to independent data monitoring committees.
d) Use of the most appropriate method of randomisation and provision of randomisation lists
for use either manually or as part of an automated system. Assist the IT Section with
implementing the randomisation systems and provide quality assurance checks at regular
intervals.
e) Provide ongoing advice on both statistical and general aspects of research to members of
the trial co-ordination, programming and clinical teams when required (e.g. advice on
problems with randomisation, eligibility, timing and interpretation of interim analyses).
f) Under supervision, present both appropriate interim information about, and results of,
research projects conducted by the CTRU. This will include preparing abstracts and
subsequently posters or oral presentations for national and international conferences and
preparing updates and presentations of final results for appropriate research groups. In
addition, the preparation of high quality manuscripts in collaboration with the project team
for submission to peer reviewed journals.
g) Under supervision, represent the CTRU at research and steering groups and within project
team groups and advertising the facilities available to researchers, as and when
appropriate.
2. Statistical consulting:
a) Provide basic clinical trials advice and statistical consultancy to health care professionals.
b) Contribute to statistical advisory sessions for NHS staff for under the Research Design
Service as required.
3. Methodological research:
a) Undertake associated methodological research (for instance, in new analytical methods for
clinical trials and new approaches to clinical trial design) under supervision.
4. Teaching:
a) Whilst teaching commitment is expected to be relatively light, the appointee would be
expected to provide input, along with other members of the CTRU, to appropriate internal
and external undergraduate and postgraduate courses in clinical trials.
5. General:
a) Keep abreast of current relevant statistical developments which impact upon the work of the
CTRU through membership of relevant societies, and through journals, conferences and
courses.
b) Provide basic statistical refereeing for reputable journals, as and when appropriate, under
supervision.
c) Maintain an up-to-date Continuing Professional Development file and identify training needs
and opportunities.
d) Other duties as specified by the Divisional Director/Principal Statistician
University Values
All staff are expected to operate in line with the university’s values and standards, which work as
an integral part of our strategy and set out the principles of how we work together. More
information about the university’s strategy and values is available at
http://www.leeds.ac.uk/comms/strategy/
Person Specification: Grade 6
Essential

BSc with major statistical component

MSc with major statistical component, or equivalent qualification

Clinical trials knowledge

Effective team worker

Effective interpersonal and communication skills, including written and presentational

Quick to grasp new concepts

Ability to use own initiative

Willing to keep abreast of / assess / use new statistical techniques

Ability to be flexible regarding meeting deadlines and prioritisation of tasks

Knowledge of a statistical computing package

Proficient in the use of MS Office.
Desirable

Knowledge of SAS computing package

Knowledge of current statistical issues in clinical trials

Has worked with people at a variety of levels

Experience of surgical trials

Experience of early phase trials

Experience of research in fields relevant to either Cancer or Comprehensive Health
Research Divisions (cancer, skin, cardiovascular or musculoskeletal disease)
Senior Medical Statistician - University Grade 7
Role Purpose
To develop and implement well planned clinical trials, at a senior level, by providing a
comprehensive statistical service for the research projects undertaken by the CTRU. In addition, to
provide general clinical trials and statistical advice to health care professionals.
Details of the Appointment
The post-holder will be accountable to a Divisional Director / Principal Statistician and responsible
to a Principal Statistician working closely with the Senior Trial Co-ordinators, CTRU Portfolio leads
and clinical collaborators in the division.
Main Duties and Responsibilities
The following list of tasks illustrates the broad range and level of activities; the exact nature of the
post will tailored to the skills and experience of the successful candidate.
1.
Management:
a) Management of own workload and timescales, and that of the Medical Statistician(s) if
applicable, agreeing schedules with the Divisional Director / Principal Statistician.
b) Assist in the training and supervision of the Medical Statistician(s) in the design and
analysis and presentation of projects conducted by the CTRU, as agreed with the
Divisional Director / Principal Statistician. In addition, assisting the Medical Statistician(s)
in their time management (if applicable).
c) Agree development plans with Divisional Director / Principal Statistician for Medical
Statisticians (if applicable).
d) Project management as required.
e) Deputise for the Divisional Director / Principal Statistician in his/her absence within the
sphere of responsibility of the post.
2.
Trials related statistics:
a) Statistical design and set up of research projects conducted by the CTRU, from the initial
approach of the health care professional through collaboration in the development of the
grant application, protocol and design of the case report forms and database to the
launch of the trial. Use sufficiently persuasive arguments with health professionals to
ensure that appropriate statistical advice is accepted. Obtain co-applicant status on grant
applications.
b) Decide on, prepare analysis plans for, and undertake appropriate statistical analysis of
the CTRU’s research projects, using appropriate statistical software, in accordance with
the relevant Standard Operating Procedures.
c) Statistical monitoring of research projects conducted by the CTRU, conduct interim
analysis of data and provide expert advice about trials (both statistical and other trial
related issues e.g. recruitment, funding) to independent data monitoring committees.
d) Determine most appropriate method of randomisation and provide randomisation lists for
use either manually or as part of an automated system. Assist programmer in the
development of automated randomisation systems.
e) Provide ongoing advice at a senior level on both statistical and general aspects of
research to members of the trial co-ordination, programming and clinical teams when
required (e.g. advice on problems with randomisation, eligibility, timing and interpretation
of interim analyses).
f) Present both appropriate interim information about, and results of, research projects
conducted by the CTRU. This will include preparing abstracts and subsequently posters
or oral presentations for national/international conferences and preparing updates and
presentations of final results for appropriate research groups. In addition, the preparation
of high quality manuscripts in collaboration with the project team for submission to peer
reviewed journals.
g) Represent the CTRU at research and steering groups and within project team groups and
advertising the facilities available to researchers, as and when appropriate.
3. Statistical consulting:
a) Provide general clinical trials and statistical consultancy at a senior level to health care
professionals.
b) Contribute to statistical advisory sessions for NHS staff for under the Research Design
Service as required.
4. Methodological research:
a) Undertake methodological research under supervision, as and when appropriate, and
introduce such methodology, if appropriate, into the CTRU by providing training to
relevant staff.
5. Teaching:
a) Whilst teaching commitment is expected to be relatively light, the appointee would be
expected to provide input, along with other members of the CTRU, to appropriate internal
and external, undergraduate and postgraduate courses in clinical trials.
6. General:
a) Keep abreast of relevant statistical developments which impact upon the work of the
CTRU through membership of relevant societies, and through journals, conferences and
courses.
b) Devise, implement and document strategies to facilitate maximising of efficiency within
the CTRU either by collaboration with the other statisticians or in collaboration with a
multidisciplinary team.
c) Provide senior statistical refereeing for reputable journals, as and when appropriate.
d) Input into Statistics team meetings at a senior level, identifying and leading agenda items
as appropriate.
e) Other duties as specified by the Divisional Director / Principal Statistician.
f) Maintain an up to date Continuing Professional Development file and identify training
needs and opportunities. Ensure Medical Statisticians have a long-term development
plan, if appropriate.
University Values
All staff are expected to operate in line with the university’s values and standards, which work as
an integral part of our strategy and set out the principles of how we work together. More
information about the university’s strategy and values is available at
http://www.leeds.ac.uk/comms/strategy/
Person Specification: Grade 7
Essential

BSc with major statistical component

MSc with a major statistical component or PhD in relevant area (or equivalent
qualification)

Previous clinical trials experience,

Has worked independently to analyse statistical data

Relevant medical statistics experience

Independent medical statistics consultancy experience

Effective team worker

Ability to use own initiative

Effective interpersonal and communication skills, including written and presentational

Quick to grasp new concepts

Willing to keep abreast of / assess / use new statistical techniques

Ability to be flexible regarding meeting deadlines and prioritisation of tasks

Extensive experience in the use of a statistical computing package

Proficient in the use of MS Office
Desirable

Knowledge of SAS computing package

Knowledge of current statistical issues in clinical trials.

Research active (as evidenced by grant applications / publications)

Evidence of project management

Experience of surgical trials

Experience of early phase trials

Experience of research in fields relevant to either Cancer or Comprehensive Health
Research Divisions (cancer, skin, cardiovascular or musculoskeletal disease)
Faculty Information
With more than 6,000 students, 1,600 staff and annual research income of £50m, the Faculty of
Medicine and Health at Leeds is bigger than some universities. Leeds has one of the largest
medical and bioscience research bases in the UK, and is an acknowledged world leader in cancer,
cardiovascular, psychiatric, genetic, musculo-skeletal and health services research. Treatments
developed in Leeds are transforming the lives of people around the world living with conditions
such as HIV, TB, diabetes and malaria.
The School of Medicine
The School of Medicine at the University of Leeds is a major international centre for research and
education. Our ambition is to improve health and reduce health inequalities, locally and globally,
through excellent scientific research and the translation of that research into healthcare practice,
and through the education of future scientific and clinical leaders who will advocate and practise
an evidence-based approach. Our major strategic aims are to:




Deliver outstanding research including basic discovery science through to applied health
research that makes a significant difference to health.
Produce exceptional graduates, clinicians, educators, doctoral and post-doctoral fellows
whose learning has been informed and inspired by our research excellence and who will
form the next generation of academic and clinical leaders.
Develop and support knowledge transfer activities that flow from our academic activities.
Create and maintain an efficient and sustainable environment for research and teaching
within an organisational culture and management style that enacts and supports the
university’s core values of community, inclusiveness, integrity and professionalism.
The School of Medicine is organised into seven Institutes. All are committed to high quality
research-led teaching, through their training of postgraduate research students, delivery of
postgraduate taught courses, and its leadership in undergraduate teaching. The School works
closely with the local NHS, having a number of jointly funded clinical posts to ensure this
relationship is effective and strong for both research and student education.
Leeds Institute of Cardiovascular and Metabolic Medicine (LICAMM), Director: Professor
Mark Kearney)
LIGHT integrates basic and clinical scientists with a common goal of understanding the
mechanisms underpinning common chronic diseases of human health and developing new
approaches to treating patients at an individual and population level. At the heart of LIGHTs
philosophy is a vibrant multidisciplinary approach to science that provides a platform to deliver
internationally competitive translational research and teaching in disorders including
cardiovascular disease, diabetes, cancer and neurodegenerative diseases) our key aim is to
improve the lives of our patients and the experience of our students.
Leeds Institute of Health Sciences (LIHS) Director: Professor Tim Ensor
LIHS delivers problem-driven research that supports decisions about the content or delivery of
healthcare. Our interdisciplinary approach incorporates expertise in applied health research
designs, health implementation sciences, social sciences, health economics, informatics and
statistics, as well as skills in communicating with basic scientists, policy makers, healthcare
providers, public and patients. We conduct research at the individual, population and
organisational level.
Leeds Institute of Medical Education (LIME) Director: Professor Trudie Roberts
LIME provides the administrative support, co-ordination and leadership for the School of
Medicine’s undergraduate medical degree, including admissions, curriculum development,
assessment, student support and clinical placement liaison. It provides the technology-enhanced
learning and innovation support for the School of Medicine. LIME also has a very active
scholarship programme of research and innovation in medical education and uses its expertise to
influence medical education policy and practice nationally and internationally. To achieve this it
works with a range of stakeholders including the academic community, the profession, the public,
regulators and policy makers.
The Leeds Institute of Cancer Studies and Pathology (LICAP) Director: Professor Tim
Bishop
The Leeds Institute of Cancer Studies and Pathology addresses both laboratory based and clinical
research into cancer with a major focus on translational science. LICAP is one of the largest
cancer Institutes in the country and has major financial support from the cancer charities. The
laboratories and clinical research are all based on the St James’s site with laboratory activities
being located in the Wellcome Trust Brenner Building and adjacent buildings while the clinical
work is based within Bexley Wing. The Institute consists of seven Sections with the following
interests:
Leeds Institute of Biomedical & Clinical Sciences (LIBACS) Director: Professor Philip
Hopkins
LIBACS undertakes clinically-driven research from the level of the gene through cellular, tissue
and organ to clinical trials. Our vision is to develop a sustainable centre of excellence for the
advancement of patient care by translating research results into clinical practise and contributing
to medical education at undergraduate and postgraduate levels. Our research interests are
encapsulated in 6 clinical themes (Gastrointestinal inflammation & tumorigenesis, Genetic
disorders, Infection & immunity, Neuroscience, Perinatal medicine, Perioperative outcomes &
technologies) underpinned by 4 generic science technology strands (Animal models, Cell biology,
Gene regulations & Genomics). We are based predominantly at the St James’s University Hospital
site.
Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), Director: Professor
Paul Emery
LIRMM is dedicated to improving diagnosis, therapy, intervention and outcome across the
spectrum of rheumatic and musculoskeletal medicine. It boasts a dynamic portfolio of research
and education, delivering wide-ranging clinical, translational and basic research across five
Sections: Clinical Musculoskeletal Medicine, Experimental Musculoskeletal Medicine, Clinical
Biomechanics and Physical Medicine, Rehabilitation Medicine and Orthopaedics. A multidisciplinary approach is the core of our activities, with significant interdisciplinary links between
Experimental and Clinical research. LIRMM’s clinical activities are focussed at Chapel Allerton
Hospital, which is also base for our NIHR Musculoskeletal Biomedical Research Unit (LMBRU)
and our basic sciences at St James’s University Hospital.
Leeds Institute of Clinical Trials Research (LICTR) Director: Professor Julia Brown
LICTR delivers innovative design, delivery and knowledge transfer in clinical trials research. Our
multidisciplinary approach, in collaboration with basic scientists, clinicians, policy makers,
healthcare providers, public and patients and University colleagues, delivers internationally
competitive research and teaching that makes a significant contribution to the evidence base for
healthcare delivery. The Institutes research is conducted through the Clinical Trials Research Unit
where we have expertise in design and conduct of complex clinical trials incorporating novel
designs to evaluate CTIMPs, complex interventions, diagnostics, medical devices and surgery.
Clinical Trials Research Unit (CTRU)
The CTRU is a National Cancer Research Institute (NCRI) accredited and UKCRC Registered
Clinical Trials Unit. It has a national and international reputation for the design and delivery of
innovative, complex, and rigorous multi-centre early to late phase clinical trials. The CTRU
provides multi-disciplinary academic leadership with input to all aspects of trials activity, including
statistical design, protocol development, randomisation, development of outcome measures, data
management, logistical issues, statistical analysis, interpretation of results and publication. Both
the CTRU’s track record in conducting innovative, complex clinical trials and its associated
methodological research (efficient trial design and analysis, novel outcome measures and patient
reported outcomes, electronic data capture) inform the academic development of this specialised
field of clinical research on a national and international level. The CTRU particularly specialise in
efficient phase 1/2 trials, biomarker driven designs, seamless phase2/3 designs, adaptive designs
and development and evaluation of complex interventions.
The CTRU is organised into three divisions Cancer, Complex Interventions, Comprehensive)
underpinned by a cross cutting methodology division, within which the portfolios reflect both
national priorities and strengths in Leeds:

Cancer Research Division - Co Directors Prof Julia Brown & Prof Walter Gregory
- Solid Tumours Portfolio
- Haematological Oncology Portfolio
- Psychosocial Portfolio
- Early Phase Trial Portfolio

Complex Interventions Division - Director Prof Amanda Farrin
- Mental Health Portfolio
- Diet and Obesity Portfolio
- Older People Portfolio
- Stroke Portfolio
- Complex Interventions Portfolio

Comprehensive Health Research Division – Director Prof Linda Sharples
- Cardiovascular Portfolio
- Musculoskeletal Portfolio
- Oral Health Portfolio
- Skin Portfolio

Methodology Division - Directors Profs Gregory, Brown, Farrin, Nixon, Sharples
- Statistical Methodology
- Efficient trial design
- Outcome development
- Complex intervention development & evaluation
- Data capture
The CTRU is currently undertaking approximately 100 trials/studies including methodological
studies that underpin scientific rigour in our trial design and analysis. The CTRU has
approximately 140 staff members and grant income is approximately £5 million per
annum. Grants have been achieved from a variety of funders: NIHR, MRC, Cancer Research UK,
BHF, ARUK, Wellcome, LRF, EORTC, European Union Biomed Programme and a variety of
Pharma companies.
Enterprise and Knowledge Transfer
National Networks
LICTR hosts and provides the leadership for the UKCRC Registered Clinical Trials Unit Network
and the NIHR Trial Managers Network.
Research Design Service
LICTR provides the academic leadership for the Leeds hub of the NIHR Yorkshire and Humber
Research Design Service and provides research design advice and consultancy through the RDS.
Teaching
LICTR is committed to high quality research-led teaching and provides training of postgraduate
research students and delivery of postgraduate taught courses.
St James’s University Hospital Campus Infrastructure and Facilities (SCIF) Director:
Professor Pam Jones
This group covers activities that cover School of Medicine functions for Institutes at St James’s
University Hospital that span more than one institute including biomedical research facilities,
student education, IT, health and safety, estates, seminars, PGR studentships and business
support functions. These functions help support the 5 adjacent buildings on the site.
There are 3 Institutes with staff and students at St James’s: LICP (Leeds Institute of Cancer
studies and Pathology), LIBACS (Leeds Institute of Biomedical and Clinical Sciences), LIRMM
(Leeds Institute of Rheumatic and Musculoskeletal Medicine). These three institutes are
dedicated to basic, translational, clinical and health research integrated with student education.
Additional Information
Terms and Conditions
Details of the terms and conditions of employment for all staff at the university, including
information on pensions and benefits, are available on the Human Resources web pages
accessible via the links on the right hand side, or at http://hr.leeds.ac.uk/policies
Disclosure and Barring Service checks
A Disclosure and Barring Service (DBS) Check is not required for this position. However,
applicants who have unspent convictions must indicate this in the ‘other personal details’ section
of the application form and send details to the Recruitment Officer
Disabled Applicants
The post is located in the Leeds Institute of Clinical Trials Research. Disabled applicants wishing
to review access to the building are invited to contact the department direct. Additional information
may be sought from the Recruitment Officer, email disclosure@leeds.ac.uk or tel + 44 (0)113 343
1723.
Disabled applicants are not obliged to inform employers of their disability but will still be covered
by the Equality Act once their disability becomes known.
Further information for applicants with disabilities, impairments or health conditions is
available in the applicant guidance.