Associate Director of Statistics
- Experience Level
- Senior Management
We are currently seeking an Associate Director of Statistics for a permanent position at a leading pharmaceutical organisation in London. In this role you will be accountable for the statistical science aspects of all clinical studies or projects conducted on behalf of the organisation.
- To conduct oneself at all times in accordance with the organisations 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.
- Accountable for all appropriate statistical aspects of a clinical study and where appropriate the development projects and report results of statistical analyses when required.
- Being the primary company contact for all statistical activities of the study or projects.
- Being the primary contact for external consultants and Service Providers for all appropriate statistical activities of the study/projects.
- To provide 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.
- Contributing to and be accountable for the setting up, implementation and reporting of clinical studies within all appropriate statistical aspects of the studies as the statistical lead for the study/projects.
- Acting as an advisor to the organisations clinical/research scientists engaged in the scientific aspects of the clinical development study/projects and providing statistical programming support to the organisations clinical scientists engaged in the study/projects.
- 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.
- Any other assigned duties.
- 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.
- Able to interact effectively at all levels within the organisation, as well as with external partners and clients.
- 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.
- 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.
- Ability to work in a multicultural environment.
- 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, 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.
- Strong statistical programming skills in SAS.
- 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.
- Proficient computer skills in Word, Excel, PowerPoint, email and Internet.
- Experience working in a team environment under time and resource pressures.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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