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 product’s 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.
What’s 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?
Our successful candidate will 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: A=Application, T=Test, I=Interview, P=Presentation
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!
Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk
