Dear Allstat,
SRG Clinical are working with an established Pharmaceutical company to
recruit for a senior Statistician who can provide advice and quality
services on project teams.
The main responsibilities of the role will include:
- By assignment, serves as lead statistician on global and regional
project teams, contributes to and participates in meetings with external
providers of statistical services and (where necessary) with health
regulatory authorities providing advise on statistical methods,
processes, workflow, costs, timelines and quality of deliverables.
- Participates in design and review of study synopses, protocols,
statistical analysis plans, case report forms and statistical/analytical
sections of reports, publications and other documents where statistical
input is required.
- Participates in cross-functional teams covering integrated analysis,
regulatory submissions, document control, procedures and quality policy
and other matters involving statistics as required.
- Ensures that statistical deliverables are completed on schedule,
budget and as per agreement with the service providers to the quality
standards and requirements, from study start-up through archiving.
- Proposes priorities, timelines and budgets for planned activities and
regularly reports on status of the projects.
- Responsible for statistics-related project budgets, project plan and
operating procedures for assigned projects.
- Advises on structuring of work processes to improve the quality and
speed of generating statistical deliverables.
- Provides statistical expertise during audits of external service
providers.
- Provides statistical expertise in internal working groups on document
control, quality policy, operating procedures and instructions.
- Keeps abreast of statistical aspects of global pharmaceutical
legislation and regulations.
Interested applicants will hold academic or higher education in
statistics, mathematics, computing/information technology, life sciences
or other discipline(s) with exposure to statistical methods, life
sciences and/or scientific research. You must also have proven
industrial experience in clinical statistics within the drug development
environment and detailed knowledge of all aspects of clinical statistics
and process of clinical research. Applicants will also have proven SAS
experience and knowledge and/or experience in data management systems,
SQL, XML, XSL, CDISC (desirable).
For a confidential discussion or further information, please contact
Priya Mukherjee on 0207 562 1791 or email an updated CV to
[log in to unmask]
Best Wishes,
Priya
Priya Mukherjee BSc (Hons) MIRP CertRP
Account Manager
Direct: +44 (0) 207 562 1791
Mobile: +44 (0) 7826 953734
Fax: +44 (0) 207 562 1799
Email: [log in to unmask] <mailto:[log in to unmask]>
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