Lead for Real World Evidence Initiatives

3 weeks ago


London, Greater London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

Position Overview

We are seeking a Real World Evidence Lead to become a vital part of our Scientific Data and Insight team within the Safety and Surveillance division.

This is a full-time role offered on a 12-month fixed-term contract/internal transition or temporary promotion basis. The position is based in a central location in London, and it is important to note that this role is exclusively available for candidates located in the UK.

Our organization is moving towards a minimum of 60% in-office attendance, as required by government guidelines.

We are implementing a flexible, hybrid working model, which requires a minimum of 8 days per month on-site to facilitate collaboration with partners and stakeholders essential for our operations. Depending on the specific role, this may increase to 12 days per month, with the remaining time available for remote work or in-office work. Some positions may necessitate more frequent on-site presence. Please consult with the hiring manager regarding remote work possibilities before accepting an offer.

About Us

The Medicines and Healthcare products Regulatory Agency is dedicated to enhancing public health through the effective regulation of medicines and medical devices, grounded in scientific research.

To fulfill our mission of safeguarding public health, we require robust vigilance processes capable of swiftly detecting, monitoring, and evaluating safety signals throughout the product lifecycle. This includes the ability to critically assess the benefit/risk balance of concerning signals and design effective risk mitigation strategies, as well as communicate effectively with patients, the public, and the healthcare system.

The Safety and Surveillance Group consolidates expertise in the safety of all medical products, supported by the Agency's data and evidence generation capabilities. Our commitment to safety informs all decision-making processes throughout the product lifecycle. The primary goal of the Safety & Surveillance portfolio is to protect the public by accurately identifying, assessing, and managing risks associated with medical products.

To support this mission, the Scientific Data & Insight function is tasked with developing in-house expertise to provide evidence for innovative approaches. The quality and timeliness of regulatory decision-making depend on access to high-quality, representative data and the ability to analyze in-house data effectively. Future initiatives will incorporate new analytical methodologies, including AI and machine learning techniques such as natural language processing and computer modeling. Therefore, enhancing data science capabilities within the MHRA is a strategic priority to meet future evidence generation needs for both medicines and devices.

Key Responsibilities:

  • Utilize expertise in epidemiology and statistics to advance the Agency's Data Strategy.
  • Contribute to the development and execution of the Real World Evidence Scientific Dialogue Program and Data, Methodology, and Endpoint Qualification.
  • Provide guidance on the utilization of Real World Data sources, including Clinical Practice Research Datalink.
  • Review and offer insights on protocols for Real World Evidence studies.

Candidate Profile:

  • Experience in statistical analysis related to the design and evaluation of observational studies.
  • Familiarity with both theoretical and practical aspects of epidemiology and biostatistics.
  • A degree or postgraduate qualification in statistics/epidemiology (or a related field with a significant statistical component) or equivalent experience.
  • Applied knowledge of medical statistics/epidemiology through professional experience or a PhD.

If you are interested in this opportunity, we encourage you to explore further.

Benefits:

  • Competitive salary with contributions towards a defined benefit pension scheme.
  • Generous annual leave policy, increasing with service.
  • Occupational Sick Pay scheme.
  • Flexible working arrangements to promote work-life balance.
  • Access to various employee assistance programs and development opportunities.


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