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Medicines and Healthcare Products Regulatory Agency

CHM Clinical Trials, Biologicals and Vaccines Expert Advisory Group

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This job is now closed

Job summary

The Commission on Human Medicines is looking to appoint one expert to the Clinical Trials, Biologicals and Vaccines Expert Advisory Group (CTBV EAG).

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 CTBV EAG is an independent advisory committee of the CHM that provide impartial advice to Ministers on matters relating to the regulation of medicines and medical devices. The CTBV EAG membership includes a wide range of highly skilled professionals who are senior and well regarded in their respective fields and lay representatives.

Main duties of the job

Expertise Required: Clinical Trials Statistician

The Member must be able to demonstrate the qualities, skills and experience to meet all the essential criteria for appointment.

About us

The Medicines and Healthcare products Regulatory Agency (MHRA) enhances and improves 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

27 February 2025

Pay scheme

Other

Salary

£200 a session

Contract

Fixed term

Duration

1 years

Working pattern

Part-time, Flexible working, Home or remote working

Reference number

K0015-CTBV25-1

Job locations

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU


Job description

Job responsibilities

For full details on job description, please refer to advert attached in this vacancy or visit:

Membership - Commission on Human Medicines - GOV.UK (www.gov.uk)

To make an application please email your application form, CV, completed monitoring form and declaration of interest form to: CSTRecruitment@mhra.gov.uk, quoting the position and reference CTBV25-1 in the subject field.

Please note that only applications submitted to CSTRecruitment@mhra.gov.uk will be considered.

Job description

Job responsibilities

For full details on job description, please refer to advert attached in this vacancy or visit:

Membership - Commission on Human Medicines - GOV.UK (www.gov.uk)

To make an application please email your application form, CV, completed monitoring form and declaration of interest form to: CSTRecruitment@mhra.gov.uk, quoting the position and reference CTBV25-1 in the subject field.

Please note that only applications submitted to CSTRecruitment@mhra.gov.uk will be considered.

Person Specification

Experience

Essential

  • The Member must be able to demonstrate the qualities, skills and experience to meet all the essential criteria for appointment.
  • Experience in statistical analysis for clinical trials, including complex and adaptive designs.
  • Experience in advanced statistical methods in early phase studies, including Bayesian modelling.
  • Current or previous experience of committee membership(s).
  • Be recognised by their peers as a leader in their field e.g. national academies and Royal Colleges.
  • Be able to assimilate and interpret complex scientific information and formulate evidence-based comments /advice at short notice.
  • Be able and prepared to contribute actively to the work of the EAG, including on issues outside of own specialism.
  • Be a skilled communicator.
  • Be willing to develop a working knowledge and understanding of UK medicines regulatory framework and procedures.
  • Maintain strict confidentiality with respect to the work of the EAG.
  • Be willing to declare conflicts of interest.
  • Be committed to the values of selflessness, integrity, objectivity, accountability, professionalism, impartiality and consistency.
Person Specification

Experience

Essential

  • The Member must be able to demonstrate the qualities, skills and experience to meet all the essential criteria for appointment.
  • Experience in statistical analysis for clinical trials, including complex and adaptive designs.
  • Experience in advanced statistical methods in early phase studies, including Bayesian modelling.
  • Current or previous experience of committee membership(s).
  • Be recognised by their peers as a leader in their field e.g. national academies and Royal Colleges.
  • Be able to assimilate and interpret complex scientific information and formulate evidence-based comments /advice at short notice.
  • Be able and prepared to contribute actively to the work of the EAG, including on issues outside of own specialism.
  • Be a skilled communicator.
  • Be willing to develop a working knowledge and understanding of UK medicines regulatory framework and procedures.
  • Maintain strict confidentiality with respect to the work of the EAG.
  • Be willing to declare conflicts of interest.
  • Be committed to the values of selflessness, integrity, objectivity, accountability, professionalism, impartiality and consistency.

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:

Committee Services - Recruitment Team

CSTRecruitment@mhra.gov.uk

Details

Date posted

27 February 2025

Pay scheme

Other

Salary

£200 a session

Contract

Fixed term

Duration

1 years

Working pattern

Part-time, Flexible working, Home or remote working

Reference number

K0015-CTBV25-1

Job locations

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU


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