JOB SUMMARY

We are currently looking for a Statistical Specialist to join our Clinical Investigations and Trials function within the Science, Research & Innovation group.
This is a full-time opportunity, on a 1 year fixed term contract/loan/internal move or temporary promotion basis, with the possibility of extension. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas.
Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.
We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly.

PERSON SPECIFICATION

Our successful candidate will have:

• Experience in the reviewing or creating the statistical aspects of the design, of conduct and analysis of Clinical Trials and experience in the preparation of statistical analysis plans and reviews of statistical data for publication or regulatory submission.
• A statistician with a relevant higher scientific qualification (MSc and/or PhD in statistics or a closely related subject).
• IT skills appropriate for an information-based organisation and a fast-paced working environment.
• Evidence of effective decision making, including clear communication of the purpose and reasons for recommendations and decisions internally and to external experts.
• Ability to work under pressure to tight timelines and to prioritise work while maintaining adherence to legal and regulatory requirements.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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SELECTION PROCESS DETAILS

We use the Civil Service Success Profiles to assess our candidates, find out more here.

• Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of Technical - A statistician with a relevant higher scientific qualification (MSc and/or PhD in statistics or a closely related subject).
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

NATIONALITY REQUIREMENTS

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements

WHAT’S THE ROLE?

The role encompasses a broad range of activities. Reporting to the Head of Clinical Investigations and Trials Operations, the successful applicant will use their statistical expertise to contribute to the risk-based review of Clinical Trial and Clinical Investigation authorisation applications l and advice companies around statistical issues for the development of new products and devices, interacting with medical colleagues, multi-disciplinary advisory committees and company representatives as required
The role holder will also be expected to contribute to policy and strategy development to maintain and enhance the reputation of the UK as a great place to conduct clinical research, identifying synergies and opportunities for streamlining across the functional areas of the Innovation and Compliance Group. Furthermore, the role holder will be involved in the generation of reports and scientific manuscripts for peer-reviewed journals.

KEY RESPONSIBILITIES:

• Carry out the risk-based review of data provided in Clinical Trial and Clinical investigation applications, making appropriate recommendations and decisions in line with the protection of public health. Contribute to the preparation of objective assessment reports or other scientific papers to expert advisory bodies to support the CIT assessment team.
• Manage own workload working in conjunction with the support team and other assessors to meet agency deadlines.
• Support the provision of scientific and regulatory advice at advice meetings with external stakeholders related to Clinical Trials and Clinical Investigations, obtaining cross-agency or external support depending on the questions posed. Provide a written response to enquiries submitted through a variety of sources, including via internal customer-facing portals and the wider civil service.
• Contribute where statistical input is required in critical Clinical Trial and medical device projects and contribute to the Innovative Licensing and Access Pathway (ILAP).
• Analyse data and write reports for internal and external use as required.
• Make a significant contribution to and / or lead in the generation of scientific manuscripts to be submitted to peer-review journals.

Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance. These roles include:

• Laboratory-based roles working directly with known pathogens
• Maintenance roles, particularly those required to work in laboratory settings
• Roles that involve visiting other establishments where vaccination is required
• Roles required to travel overseas where specific vaccination may be required