Overview
A non-clinical position has arisen for a clinical trial statistician to be the academic lead and provide senior oversight and leadership to the Sheffield Clinical Trials Research Unit (CTRU) oncology clinical trials portfolio.
Sheffield CTRU has received substantial infrastructure funding to grow and diversify its portfolio of multi-centre cancer clinical trials. The post holder will be responsible for the leadership of trial design, grant development, and submission, as well as senior-level study implementation, with a specific focus on oncology-based CTIMPs (Clinical Trials of Investigational Medicinal Products). You will work closely with the CTRU Director, CTRU staff and Chief Investigators to secure research funding and ensure that studies under your supervision are implemented in accordance with randomised controlled trial scientific principles, the study protocols, and regulatory standards.
You will provide academic and methodological leadership to all specialist oncology studies within the CTRU’s portfolio, ensuring that these studies are designed, conducted, analysed and reported to the highest possible standards and are compliant with professional, national, and international regulatory frameworks.
Experience of the design, management, conduct/implementation, analysis and reporting of multi-centre randomised controlled trials is essential. We are seeking a candidate with a proven track record of working within the oncology research field, possessing a deep understanding of the Medicines for Human Use (Clinical Trials) Regulations as they apply to complex cancer research.
Main duties and responsibilities
You will be responsible for:
- Providing senior oversight and leadership to the CTRU oncology clinical trials portfolio, particularly the Yorkshire Cancer Research (YCR) Infrastructure grant ensuring that the project meets its key milestones and deliverables.
- Provide statistical input for the design, conduct, implementation, analysis and reporting of oncology trials across the CTRU portfolio.
- Drive methodological research to advance efficient and patient-centred trial designs.
- Work collaboratively within a multidisciplinary team including clinicians, statisticians, trial managers and other research professionals.
- Develop a specialist portfolio of oncology research and act as CTRU Lead in collaboration with clinical investigators through designing studies, submitting research applications, and securing significant external research income/grant funding.
Ensure the cancer research studies for which you are the CTRU lead are undertaken in accordance with randomised controlled trial scientific principles and the protocol.
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Oversee Quality Assurance processes within the CTRU.
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Ensure that all relevant regulatory standards for clinical trials are adhered to.
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- Support preparation for and response to MHRA inspections.
- Lead on the preparation and publication of papers for high-impact oncology and academic journals, that are internationally excellent or world leading in terms of originality, significance and rigour.
- Lead on the presentation of findings at international cancer conferences and academic forums.
- Use your methodological expertise to undertake research and translational activities that result in demonstrable impact.
Undertake undergraduate and post-graduate teaching, supervision and examining, within the School of Medicine and Population Health.
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- Contribute fully as a researcher, teacher and leader, fulfilling the appropriate requirements of the University’s Academic Career Pathway Framework (ACP).
- Make ethical decisions in your role, embedding the University sustainability strategy into your working activities wherever possible.
- Any other duties, commensurate with the grade of the post.
Person Specification
Our diverse community of staff and students recognises the unique abilities, backgrounds, and beliefs of all. We foster a culture where everyone feels they belong and are respected. Even if your past experience doesn't match perfectly with this role's criteria, your contribution is valuable, and we encourage you to apply. Please ensure that you reference the application criteria in the application statement when you apply.
Academic Qualifications: Postgraduate qualification in Medical Statistics or a closely related discipline.
Extensive experience in design and analysis of clinical trials within oncology, with a deep understanding of cancer-specific trial complexities.
Expertise in complex and innovative trial designs commonly used in oncology (e.g., adaptive designs, master protocols, umbrella/basket trials, dose-finding Phase I/II designs, and biomarker-driven trials).
High and distinctive standing within and outside academia including: major contributions to the area/field through academic or professional achievement; recognised expertise.
Sound understanding of the scientific principles of RCTs, including experience with innovative/adaptive trial designs (e.g., basket or platform trials) relevant to precision medicine.
Proven, substantial experience acting as lead statistician on multi-centre oncology clinical trials.
Experience working on CTIMPs and thorough knowledge of The Medicines for Human Use (Clinical Trials) Regulations 2004 and ICH Good Clinical Practice (GCP).
Grant Development & Income: Extensive experience collaborating with senior clinical investigators to design, develop, and successfully secure major research grants (e.g., NIHR, CRUK, MRC or major charities).
Academic Output: A strong track record of high-quality, peer-reviewed clinical trial research papers published in high-impact journals.
Leadership & Mentorship: Experience in supervising junior staff and mentoring early-career researchers or clinical fellows (e.g., NHS Consultants/AHPs) in trial development.
Communication & Stakeholder Engagement: Excellent skills in maintaining relationships with Chief Investigators, trial funders, and Cancer Patient and Public Involvement (PPI) panels.
Strategic Problem Solving: Ability to develop creative approaches to complex trial problems (e.g., recruitment barriers in oncology) with an appreciation for long-term sustainability and strategic aims.
Further Information
Full-time / Part-time (a minimum of 0.6FTE)
- Trial Manager
- Study Managers
- Study Delivery Staff
https://sheffield.ac.uk/ctru
For informal enquiries about this job contact Prof Matt Hammond, Director of the Sheffield Clinical Trials Research Unit: on
[email protected]
Next steps in the recruitment process
It is anticipated that the selection process will take place in June. This will consist of a 15 minute presentation and subsequent interview. If you need any support, equipment or adjustments to enable you to participate in any element of the recruitment process you can contact
[email protected].
Our vision and strategic plan
We are the University of Sheffield. This is our vision: sheffield.ac.uk/vision ().
What we offer
- A minimum of 41 days annual leave including bank holiday and closure days (pro rata) with the ability to purchase more.
- Flexible working opportunities, including hybrid working for some roles.
- Generous pension scheme.
- A wide range of discounts and rewards on shopping, eating out and travel.
- A variety of staff networks, providing opportunities for social interaction, peer support and personal development (for example, Race Equality, LGBT+, Women’s and Parent’s networks).
- Recognition Awards to reward staff who go above and beyond in their role.
- A commitment to your development access to learning and mentoring schemes; integrated with our Academic Career Pathways
- A range of generous family-friendly policies
- paid time off for parenting and caring emergencies
- support for those going through the menopause
- paid time off and support for fertility treatment
- and more
We are a Disability Confident Employer. If you have a disability and meet the essential criteria for this job you will be invited to take part in the next stage of the selection process.
