Medicines and Healthcare Products Regulatory Agency

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

Information:

This job is now closed

Job summary

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.

Main duties of the job

The Agency is committed to supporting innovative approaches to data and evidence generation across the product lifecycle. This role will focus on delivering our forthcoming Data Strategy.

The Data Strategy articulates the Agencys ambition in data, digital technologies and real world evidence generation. A key purpose of this role is to ensure the ambitions within the Data Strategy are achieved by supporting a programme of scientific dialogue and regulatory guidance on the use of Real World Data and Real World Evidence. The role offers an exciting opportunity to be at the forefront of regulatory and scientific aspects of Real World Data.

The postholder will need to work across the Agency, with partners from across the UK health data ecosystem and key stakeholders

About us

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.

Details

Date posted

12 April 2024

Pay scheme

Other

Salary

£42,869 a year

Contract

Fixed term

Duration

12 months

Working pattern

Full-time, Home or remote working

Reference number

K0015-24-0000

Job locations

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU


Job description

Job responsibilities

The Data Strategy articulates the Agencys ambition in data, digital technologies and real world evidence generation. A key purpose of this role is to ensure the ambitions within the Data Strategy are achieved by supporting a programme of scientific dialogue and regulatory guidance on the use of Real World Data and Real World Evidence. The role offers an exciting opportunity to be at the forefront of regulatory and scientific aspects of Real World Data.

The postholder will need to work across the Agency, with partners from across the UK health data ecosystem and key stakeholders.

Key responsibilities and results areas

  • Apply knowledge and skills in epidemiology and statistics to support the delivery of the Agencys 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

  • Assess and advise on the quality and appropriateness of data sources, statistical and epidemiological methodologies, and endpoints

Job description

Job responsibilities

The Data Strategy articulates the Agencys ambition in data, digital technologies and real world evidence generation. A key purpose of this role is to ensure the ambitions within the Data Strategy are achieved by supporting a programme of scientific dialogue and regulatory guidance on the use of Real World Data and Real World Evidence. The role offers an exciting opportunity to be at the forefront of regulatory and scientific aspects of Real World Data.

The postholder will need to work across the Agency, with partners from across the UK health data ecosystem and key stakeholders.

Key responsibilities and results areas

  • Apply knowledge and skills in epidemiology and statistics to support the delivery of the Agencys 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

  • Assess and advise on the quality and appropriateness of data sources, statistical and epidemiological methodologies, and endpoints

Person Specification

Qualifications

Essential

  • 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

Experience

Essential

  • 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
Person Specification

Qualifications

Essential

  • 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

Experience

Essential

  • 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

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU


Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU


Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Employer contact details

For questions about the job, contact:

The Resourcing Team

Careers@mhra.gov.uk

Details

Date posted

12 April 2024

Pay scheme

Other

Salary

£42,869 a year

Contract

Fixed term

Duration

12 months

Working pattern

Full-time, Home or remote working

Reference number

K0015-24-0000

Job locations

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU


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