Statistical Assessor

This is a full-time opportunity on a permanent basis. The role will be based in 10 South Colonnade Canary Wharf London E14 4PU.

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.

Who are we

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices underpinned by science and research.

The objective of the Healthcare Quality and Access portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access as well as ensuring compliance with regulations and standards.

The Innovative Medicines function delivers a risk appropriate critical appraisal of quality safety and efficacy of innovative medicinal products determining whether a products benefits outweigh the risks. It aims to accelerate their route to market to drive earlier patient access. Through this function the Agency will be seen as a leader in facilitating early access to safe and innovative medicines attracting the life sciences sector and contributing to positive patient experience and to the improvement of public health outcomes.

Whats the role

As part of the evaluation of data submitted to support an application for a product license it is important to evaluate the clinical study designs and statistical analysis methods used in the clinical studies submitted and to critically interpret the results presented and this will be the main focus of the role. Reporting to the Statistics Team Lead in Innovative Medicines the successful applicant will use their statistical expertise to review Marketing Authorisation Applications and advise on good drug development interacting with medical colleagues multi-disciplinary advisory committees and company representatives as required.

Key responsibilities:

• Carry out the assessment of clinical study data provided in marketing authorisation applications and applications made through EAMs (early access to medicine scheme) making appropriate recommendations and decisions aligned to the protection of public health.
• Provide reliable timely and appropriate scientific and regulatory advice to applicants at meetings and in writing reflecting contemporary regulatory guidance and relevant regulatory decisions. Advice should be given in line with protection of public health and to promote innovation specifically to promote efficient development without compromising the evidence base for regulatory decision making.
• Prepare present and discuss objective assessments or other scientific papers at expert advisory groups e.g. the Commission on Human Medicines as needed.
• Review protocols for clinical investigations planned to be run in the UK.

Who are we looking for

Oursuccessful candidatewill demonstrate the following.

• MSc or PhD in statistics or closely related subject or equivalent experience
• Relevant work experience and knowledge relating to the design analysis and interpretation of clinical studies.
• Excellent written and verbal communication skills. Ability to write authoritative reports and convey information through effective verbal communication and presentational skills appropriate to the target audience.
• Knowledge of relevant guidelines regulations and procedures and/or ability to acquire such knowledge quickly.
• Ability to work under pressure to tight timelines and to prioritise work.

Person Specification:

Method of assessment:AApplication TTest IInterview PPresentation

Behaviour Criteria:

• Communicating and Influencing:Excellent written and verbal communication skills. Ability to write authoritative reports and convey information through effective verbal communication and presentational skills appropriate to the target audience. (A I)

• Delivering at Pace:Ability to work under pressure to tight timelines and to prioritise work. (A I)

• Working Together: Evidence of effective interpersonal skills in a range of situations. (A I)

Experience Criteria:

• Relevant work experience and knowledge relating to the design analysis and interpretation of clinical studies. (A I)

Technical Criteria:

• MSc or PhD in statistics or closely related subject or equivalent experience (A I)

• Knowledge of relevant guidelines regulations and procedures and/or ability to acquire such knowledge quickly. (A I)

• IT skills appropriate for an information-based organisation and a fast-paced working environment. (A I)

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

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The selection process:

We use the Civil Service Success Profiles to assess our candidatesfind out more here.

• Online application form including questions based on theBehaviour 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.

• Interview which can include questions based on theBehaviour Experience and Technical Success Profiles.

In the instance that we receive a high number of applications we will hold an initial sift based on the lead criteria ofRelevant work experience and knowledge relating to the design analysis and interpretation of clinical studies.

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 allowsufficienttime. You can view the competencies for this role in the job description.

Use of AI in Job Applications

Artificial Intelligence can be a useful tool to support your application however all examples and statements provided must be truthful factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others or generated by artificial intelligence as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see ourcandidate guidancefor more information on appropriate and inappropriate use.

If you require any disability related adjustments at any point during the process please contact as soon as possible.

Closing date:22^nd February 2026

Shortlisting date: from 23^rd February 2026

Interview date:from 9^th March 2026

If you need assistance applying for this role or have any other questionsplease contact

Candidates will be subject to UK immigration requirements as well as Civil Service nationality information on whether you are able to apply is availablehere.

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must completebasic personnel security standard checks.

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.

Applicants who are successful at interview will be as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicants details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes including Tax-Free Childcare. Determine your eligibilityhere.

Staffjoining onpromotion will receive up to a 10% increaseoftheir current basic salary or the pay band minimum whichever is the greater.

The individual will notretainany allowances paid by the former department/Agency unless there arespecial circumstances such as a reserved right to those allowances on transfer.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact.

In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointmenton the basis ofmerit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint you should firstly contact

If you are not satisfied with the response you receive you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1Horse Guards Road

London

SW1A 2HQ