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Statistical Science Manager (Senior Manager) – SME Pharma – London - Hybrid / Remote

Employer
Warman O’Brien
Location
London (Greater) (GB)
Salary
Up to £70,000 plus bonus and benefits
Start date
4 Aug 2022
Closing date
3 Sep 2022

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Job Details

We have just partnered with this global pharma, who are looking for a Statistical Science Manager to join their friendly team in their London office. The position is offered as office based with flexibility for home working.

The Statistical Science Manager is responsible and accountable for the statistical science aspects of all assigned clinical studies or project(s) conducted on behalf of the company. The Statistical Science Manager will be responsible for the effective communication within the company and, where appropriate, with external organisations of the issues and actions related to the successful completion of statistical activities within the study/project(s).   

You will lead and manage all statistical activities within one or more clinical studies or project(s) working closely with other Drug Development colleagues, internal and external departments, external consultants, key opinion leaders, medical advisors and CRO’s/contractors, under the guidance of the Head of Data & Regulatory Sciences to ensure the quality and integrity of the data is maintained whilst identifying, and minimising where possible, risks to the project(s).

You may also fulfil the role of Study Statistician on one or more clinical studies.

Responsibilities:

Key responsibilities shall include but are not limited to:

  • Conduct oneself at all times in accordance with company Quality Management System, working practices and Good Clinical Practice/Good Manufacturing Practice regulations, and ensure training in these areas is kept up-to-date at all times
  • Responsible and accountable for all appropriate statistical aspects of a clinical study and where appropriate the development project(s).
  • Report results of statistical analyses when required. Be able to communicate the results of statistical analyses to non-statistical people. Being the primary contact for all statistical activities of the study or project(s).
  • Being the primary contact for external consultants and Service Providers (SPs) for all appropriate statistical activities of the study/project(s).
  • Providing appropriate statistical review and interpretation of any pre-clinical data and clinical data from other on-going studies conducted by other parties for the same compound. 
  • Identifying relationships and trends in data, as well as any factors that could affect the results of research. Contributing to and be accountable for the setting up, implementation and reporting of clinical study(s) within all appropriate statistical aspects of the study(s) as the statistical lead for the study/project(s). These responsibilities shall include but are not limited to;
  • Providing input into the selection of SPs/contractors from a statistical aspect in conjunction with the project team and management.
  • Being responsible and accountable for developing and maintaining study documents within all appropriate statistical aspects of the study(s), e.g., including but not limited to, the statistical analysis plan.
  • Providing input to study documents, e.g., a project plan, study protocol, data management plan, operational documents, clinical study report, and/or authoring relevant sections of study documents. Reviewing and approving SPs’ study documentation for statistical areas.
  • Managing SPs/contractors and overseeing their performances and quality of work to ensure they meet an agreed project plan, contracts and any study specific requirements within all appropriate statistical aspects of the project(s).
  • Monitoring the relevant budgets relating to SPs/contractors and ensuring the budget is maintained and being proactive in reporting any potential out of scope activities to the Head of Data Science Reporting the status of statistical activities for studies and projects to the study/project and management teams.
  • Ensuring company statistics-related processes are compliant with applicable regulatory requirements and being part of a team for the review, maintenance and update of statistics-related SOPs and associated documents.
  • Acting as an advisor to clinical/research scientists engaged in the scientific aspects of the clinical development study/project(s) and providing statistical programming support to the clinical scientists engaged in the study/project(s).
  • Contributing to the development and maintenance of policies, SOPs and company documents. Ensuring learning and knowledge transfer during and at the completion of the project. Continue to update knowledge and keep abreast of changes within the field of Statistics in Clinical Development. To maintain a library of statistical material to facilitate the creation of potential future training materials.
  • Be part of a team responsible for the global harmonisation of standards and processes for Data Science.

Education, Experience, Knowledge, Skills and Abilities

  •   Minimum MSc in Statistics, Biometrics or Medical Statistics or related discipline, or equivalent combination of education and experience. Significant, relevant, in depth and demonstrated experience within the pharmaceutical, contract research organisation (CRO), biotechnology or medical sector, including clinical program design, clinical trial design, analysis and reporting. Demonstrated proficiency with ICH/GCP guidelines, related statistical guidelines and knowledge of other regulatory guidelines relating to statistics and programming Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment. Ability to oversee and manage CROs conducting statistical aspects of clinical trials and to ensure high quality deliverables are received. Strong statistical programming skills in SAS. Significant experience with CDISC/ADaM Experience with sample size software (e.g. Nquery, EAST) and randomisation procedures. Early phase knowledge is desirable including knowledge of mixed modelling techniques and familiarity with pharmacokinetic data. Able to interact effectively at all levels within the organisation, as well as with external partners and clients. Proven ability for working independently with minimal supervision. A can-do attitude with a willingness to get actively involved. Must be meticulous and methodical, with the ability to review both data and procedures in detail and the ability to see the greater overall picture. Experience working in a team environment under time and resource pressures. Strong analytical and problem-solving skills. Good negotiation skills. Excellent communication skills (English verbal and written) including the ability to convey statistical concepts to non-statisticians, organisation, presentation and time management skills.

What to do next: If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible.

Not what you’re looking for? Please contact Aimee Weston at aimee@warmanobrien.com  for a confidential discussion about potential opportunities.

 

Company

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Warman O’Brien is a global specialist Life Sciences Recruitment Partner across the UK, Europe, USA and APAC. We recruit top talent across a number of functional areas including:

  • Biometrics
  • Data Sciences
  • Quality Assurance
  • Regulatory Affairs
  • Clinical Research
  • Discovery Sciences
  • C-Suite
  • Medical Affairs

We cover contract and permanent vacancies, executive search, and SOW for companies across the pharmaceutical industry.  

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Find out more on our website warmanobrien.com/

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Company info
Website
Telephone
+44 (0) 2033255075
Location
Floor 5
Regal House
70 LONDON ROAD
Twickenham
TW1 3QS
United Kingdom

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