Job summary
The Royal Marsden NHS Foundation Trust has an exciting opportunity for a passionate and dedicated Lead/Principal Statistician to Join our Clinical Trials Unit. This role offers an exciting opportunity to Lead a team in applying innovative statistical approaches.
The Royal Marsden has a vital role in championing change and improvement in cancer care through research and innovation, education, and leading-edge practice. We are incredibly proud of our international reputation for pushing the boundaries and for our ground-breaking work ensuring our patients receive the very best and latest in cancer treatment and care. RM CTU is a UKCRC accredited clinical trials unit, with a wide-ranging portfolio of cancer research trials across multiple tumour groups. Our UKCRC accreditation indicates RM CTU as a centre of excellence with a strong track record of coordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long-term viability of capacity for trial management. We would welcome your application.
Main duties of the job
RM CTU is a UKCRC accredited clinical trials unit, with a wide-ranging portfolio of cancer research trials across multiple tumour groups. Our UKCRC accreditation indicates RM CTU as a centre of excellence with a strong track record of coordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long-term viability of capacity for trial management.
Our unique feature among our CTUs is that our trial management expertise is aligned with and integrated with our clinical knowledge and expertise at The Royal Marsden. This is a senior management post within the Clinical Research Directorate. The post-holder will work jointly with the Head of Clinical Trial Management, to oversee the statistical, database programming and management of all RM Sponsored, and where we act as a CRO for interventional clinical trials, within the RM CTU and across the tumour-specific clinical units
About us
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital.
At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- To lead the statistical team so they can provide expert advice to investigators on complex clinical trial designs and novel and standard statistical methodologies, i.e. adaptive designs, dose-response model selection and analysis, Bayesian methods, biomarker studies.
- To promote the use of statistical concepts within research across the Trust.
- To ensure the statistical service delivered is efficient, effective, and compliant to all applicable regulations.
- Take responsibility for our database and its development needs.
- To write and maintain the statistical section of protocols and statistical analysis plans, advising the most appropriate statistical methods
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- To lead the statistical team so they can provide expert advice to investigators on complex clinical trial designs and novel and standard statistical methodologies, i.e. adaptive designs, dose-response model selection and analysis, Bayesian methods, biomarker studies.
- To promote the use of statistical concepts within research across the Trust.
- To ensure the statistical service delivered is efficient, effective, and compliant to all applicable regulations.
- Take responsibility for our database and its development needs.
- To write and maintain the statistical section of protocols and statistical analysis plans, advising the most appropriate statistical methods
Person Specification
Education/Qualifications
Essential
- First degree or equivalent in a subject with a statistical component
- Higher Qualification in statistics and appropriate experience in applied statistics, in the role of medical statistician
Research Skills Experience
Essential
- Conduct of research on human participants as a clinical or nonclinical scientist or in a technical role
- Management within a research funding organisation
- Management of NHS R&D activity.
- Clinical research management in an academic unit or the pharmaceutical industry.
- Experience of working in an academic research environment.
- Evidence of initiation or central coordination of research collaborations
- Proven project management experience in clinical trials, epidemiology, or public health setting.
- Track record in providing expert advice and guidance on trials related issues
- Clear understanding of and interest in cancer research and in particular clinical cancer research and the ability to communicate this effectively to others.
- Experience of managing Quality Assurance documentation and systems.
- Experience of ethics, regulatory and funding submissions, and reports
- Excellent knowledge of the EU Clinical Trials Directive, Good Clinical Practice and Research Governance requirements together with the ability to disseminate the knowledge and information.
- Experience of high-level negotiations i.e. with pharmaceutical companies, sponsors, funding bodies and Chief Investigators.
Desirable
- Ability to lead and develop scientific projects.
- Ability to make scientific and logistical input into trial protocols.
- Project management/clinical trials experience gained in a number of multi centre, phase 1- III randomised clinical trials.
- Specialist knowledge/experience of international trial negotiation/set up.
- Experience of working in the cancer field.
- Experience of preparing for regulatory/sponsor inspection
- Manuscript preparation.
Management Skills / Experience
Essential
- Excellent relationship management skills.
- Proven track record of leadership qualities with experience of working at a senior level (i.e. management team or equivalent).
- Significant experience of successfully designing and implementing new ways of working, including new processes and systems.
- Proven track record of managing, directing, and supporting staff.
- Experience and ability to make effective and enthusiastic contributions to scientific, strategic and management meetings.
- Significant experience of strategic planning and management
Desirable
- Experience of recruiting staff.
Other requirements
Essential
- Ability to work with clinical and management colleagues at all levels across a range of organisations
- Ability to handle information and situations of a confidential, delicate or difficult nature with authority and tact
- Ability to be proactive in "horizon scanning" i.e. identification of new issues.
- Ability to work to high professional standards at all times.
- Ability to project a positive and professional image of the joint institution and RM CTU to- stakeholders from the UK and from overseas
- Ability to see RM CTU's work in the context of national and international activities
- Excellent organisational and time management skills to manage and deliver a range of tasks and projects to tight deadlines.
- Effective oral and written communication skills.
- Excellent interpersonal skills to facilitate liaison with colleagues
- Excellent knowledge of PC based Windows and Microsoft Office software.
Desirable
- Experience of presenting at national /international meetings
- Ability to work across internal teams and external organisations.
- Skills in preparing and delivering complex presentations and reports for a range of audiences.
- Ability to chair meetings effectively.
PERSONAL QUALITIES
Essential
- Experience of working in a proactive and forward looking way with clinical academics.
- Flexible and innovative approach to working, including problem solving through lateral thought, management of change and a desire to develop knowledge.
- Ability to provide strong strategic leadership alongside The Head of Clinical Trials, for RM CTU under the direction of the Director.
- Highly motivated with the ability to influence and inspire others
- Commitment to work within a team in an effective and supportive way
- Effective decision maker.
- Ability to work effectively under direction and on own initiative
- Strong attention to detail.
Person Specification
Education/Qualifications
Essential
- First degree or equivalent in a subject with a statistical component
- Higher Qualification in statistics and appropriate experience in applied statistics, in the role of medical statistician
Research Skills Experience
Essential
- Conduct of research on human participants as a clinical or nonclinical scientist or in a technical role
- Management within a research funding organisation
- Management of NHS R&D activity.
- Clinical research management in an academic unit or the pharmaceutical industry.
- Experience of working in an academic research environment.
- Evidence of initiation or central coordination of research collaborations
- Proven project management experience in clinical trials, epidemiology, or public health setting.
- Track record in providing expert advice and guidance on trials related issues
- Clear understanding of and interest in cancer research and in particular clinical cancer research and the ability to communicate this effectively to others.
- Experience of managing Quality Assurance documentation and systems.
- Experience of ethics, regulatory and funding submissions, and reports
- Excellent knowledge of the EU Clinical Trials Directive, Good Clinical Practice and Research Governance requirements together with the ability to disseminate the knowledge and information.
- Experience of high-level negotiations i.e. with pharmaceutical companies, sponsors, funding bodies and Chief Investigators.
Desirable
- Ability to lead and develop scientific projects.
- Ability to make scientific and logistical input into trial protocols.
- Project management/clinical trials experience gained in a number of multi centre, phase 1- III randomised clinical trials.
- Specialist knowledge/experience of international trial negotiation/set up.
- Experience of working in the cancer field.
- Experience of preparing for regulatory/sponsor inspection
- Manuscript preparation.
Management Skills / Experience
Essential
- Excellent relationship management skills.
- Proven track record of leadership qualities with experience of working at a senior level (i.e. management team or equivalent).
- Significant experience of successfully designing and implementing new ways of working, including new processes and systems.
- Proven track record of managing, directing, and supporting staff.
- Experience and ability to make effective and enthusiastic contributions to scientific, strategic and management meetings.
- Significant experience of strategic planning and management
Desirable
- Experience of recruiting staff.
Other requirements
Essential
- Ability to work with clinical and management colleagues at all levels across a range of organisations
- Ability to handle information and situations of a confidential, delicate or difficult nature with authority and tact
- Ability to be proactive in "horizon scanning" i.e. identification of new issues.
- Ability to work to high professional standards at all times.
- Ability to project a positive and professional image of the joint institution and RM CTU to- stakeholders from the UK and from overseas
- Ability to see RM CTU's work in the context of national and international activities
- Excellent organisational and time management skills to manage and deliver a range of tasks and projects to tight deadlines.
- Effective oral and written communication skills.
- Excellent interpersonal skills to facilitate liaison with colleagues
- Excellent knowledge of PC based Windows and Microsoft Office software.
Desirable
- Experience of presenting at national /international meetings
- Ability to work across internal teams and external organisations.
- Skills in preparing and delivering complex presentations and reports for a range of audiences.
- Ability to chair meetings effectively.
PERSONAL QUALITIES
Essential
- Experience of working in a proactive and forward looking way with clinical academics.
- Flexible and innovative approach to working, including problem solving through lateral thought, management of change and a desire to develop knowledge.
- Ability to provide strong strategic leadership alongside The Head of Clinical Trials, for RM CTU under the direction of the Director.
- Highly motivated with the ability to influence and inspire others
- Commitment to work within a team in an effective and supportive way
- Effective decision maker.
- Ability to work effectively under direction and on own initiative
- Strong attention to detail.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
