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Head of Real World Evidence Operations
2 months ago
Position Overview
We are seeking a Real World Evidence Lead to become a vital part of our Scientific Data and Insight division within the Safety and Surveillance team.
This is a full-time role offered on a 12-month fixed-term contract/internal transfer or temporary promotion basis. The position is located in London. Please note that this role is exclusively available for candidates based in the UK.
Government entities are advancing towards a minimum of 60% in-office attendance.
We are adopting a flexible, hybrid working model, requiring a minimum of 8 days per month on-site to facilitate collaboration and engagement with partners and stakeholders essential for our operations. Depending on the role's nature, this may increase to 12 days per month, with the remaining time worked either remotely or in the office. Some positions may necessitate more frequent on-site presence. Remote work options may be available for specific roles; please discuss this with the hiring manager prior to 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, supported by scientific research.
To fulfill our core mission of safeguarding public health, we require robust monitoring processes capable of swiftly identifying, tracking, and assessing safety signals throughout the product lifecycle. This includes the ability to critically analyze the benefit/risk balance of concerning signals and devise effective risk mitigation strategies, ensuring clear communication with patients, the public, and the healthcare system. The Safety and Surveillance Group consolidates expertise in the safety of all medical products with enforcement capabilities, supported by the Agency's data and evidence generation capabilities.
Safety is central to all our decision-making processes throughout the product lifecycle. The primary objective of the Safety & Surveillance portfolio is to protect the public by accurately identifying, evaluating, and managing risks associated with medical products. We leverage the best available science, technology, information, and professional practices to safeguard patients in innovative ways.
To support this mission, the Scientific Data & Insight function will focus on developing in-house expertise to provide evidence for these new methodologies. 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 include the application of advanced analytical techniques, including AI and machine learning methodologies such as natural language processing and computer modeling. Therefore, enhancing our 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 support 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.
- Advise on the utilization of Real World Data sources, including Clinical Practice Research Datalink.
- Review and provide guidance 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) or equivalent experience.
- Applied knowledge of medical statistics/epidemiology through professional experience or a PhD.
If you are interested in learning more about this opportunity, please reach out for further information.
Benefits:
- Competitive salary with contributions towards a Civil Service Defined Benefit Pension scheme.
- Annual Leave: 25 days of annual leave upon entry, increasing by one day for each completed year of service, up to a maximum of 30 days, plus 8 bank holidays.
- Privilege Leave: 1 day.
- Working Hours: 37 hours per week for full-time staff, with pro-rata for part-time staff.
- Occupational Sick Pay: One month full pay/one month half pay upon entry, increasing by one month for each completed year of service, up to a maximum of five months full pay/half pay.
- Mobility: Mobility clause in contracts allowing staff to work across the Civil Service.
- Flexible working arrangements to support a healthy work-life balance.
- Access to various employee assistance services and development opportunities.
