Real World Evidence Lead - £42,869 p.a. + benefits

Job summary

We are currently looking for aReal World Evidence Leadto join ourScientific Data and InsightFunction within theSafety and SurveillanceGroup.

This is afull-timeopportunity, on a12 month fixed term contract/internal move or temporary promotionbasis. 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.�

Job description

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.��

To deliver effectively on our central mission of protecting public health, we need robust vigilance processes that are able to quickly detect, monitor and evaluate safety signals across the product lifecycle, the ability to critically evaluate the benefit/risk balance of signals of concern and design effective risk mitigations, to communicate effectively to patients and the public and a healthcare system able to implement them.� The Safety and Surveillance Group brings together into a single integrated structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agency�s data and evidence generating capabilities complementing our signal generating abilities delivered via the common vigilance platform SafetyConnect.

Safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying, assessing and managing the risks associated with medical products. In every aspect of this work, we harness the best science, technology, information and professional practice to protect patients in new and impactful ways.

In support of this mission, the Scientific Data & Insight function will be responsible for developing expertise in house to deliver evidence to underpin these new approaches. Quality and speed of regulatory decision making is dependent on having access to high-quality, representative data in a timely fashion but also being able to access and analyse in house data and information in the most effective way. In the future this will include the application of new analytical methodologies including AI and machine learning methods such as natural language processing, large language models and computer modelling and simulation approaches. Hence developing and strengthening capacity and capability in data science within MHRA is a key strategic objective to ensure we are best placed to address the future evidence generation needs for both medicines and devices.

Key responsibilities:�

Apply knowledge and skills in epidemiology and statistics to support the delivery of the Agency�s Data Strategy Contribute to the development and delivery of the Real World Evidence Scientific Dialogue Programme and Data, Methodology, and Endpoint Qualification Provide advice on the use of Real World Data sources such as Clinical Practice Research Datalink Review and advise on protocols for Real World Evidence studies

Person specification

Experience of statistical work relating to the design and analysis of observational studies Familiarity with both the technical and practical aspects of epidemiology and biostatistics A degree or postgraduate qualification in statistics/epidemiology (or with a major statistical component) or equivalent experience Applied knowledge of medical statistics/epidemiology through work experience or through a PhD

If you would like to find out more about this fantastic opportunity,

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Benefits

Alongside your salary of �42,869, Medicines and Healthcare Products Regulatory Agency contributes �12,419 towards you being a member of the Civil Service Defined Benefit Pension scheme. Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays�Privilege Leave: 1 day��Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff�Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay�Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil ServiceCivil Service Pension Scheme.� Please see the link for further information For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on �Flexible working to ensure staff maintain a healthy work-life balance�Interest free season ticket loan or bike loan�Employee Assistance Services and access to the Civil Service Benevolent Fund�Eligibility to join the Civil Service Motoring Association (CSMA)Variety of staff and Civil Service clubs�On-going learning and development�

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