Background:
This is a fantastic opportunity based in London for one of thee most
respected companies in the industry today.
They have a solid pipeline and an enviable developing pipeline too.
Their pharmaceutical arm has a European division based in London who can
boast
One of the highest staff retention rates in the industry today.
There are two vacancies for a Senior Statistician, either permanent or
12 month contract through your Ltd Company
Or agency managed.
A competitive salary will be offered as well as competitive benefits
including pension,
bonus, car allowance, health and life assurance.
Primary Duties:
The purpose of the Senior Statistician position is to provide
program-level statistical expertise by:
Designing, analyzing and interpreting clinical studies and programs
conducted.
Standardizing study design, analysis methodology and presentations to
maximize global data integratability.
Leveraging external vendors providing statistical services to achieve
quality, timely, cost-effective study deliverables.
You will also represent the statistics function in support of clinical
studies led from either the US or EU.
Provide statistical input to feasibility assessments, development and
submission plans and defense of
Regulatory submissions.
Provide accurate, statistically appropriate outputs included in
protocols, statistical analysis plans, study reports and
regulatory submission documents.
Implement project level database (including derived database), analysis
and reporting standards.
Plan and direct study-level analysis and reporting activities including
work of other programmers.
Identify study-level vendor requirements and participate in the
evaluation/selection of BDM vendors. Provide technical oversight
of statistical activities of external vendors to ensure timeliness and
quality of analysis data and statistical outputs.
Review and approve key statistical vendor deliverables.
Anticipate and communicate resource and quality issues that may impact
deliverables or timelines.
Propose and implement solutions.
Experience and Qualifications:
PhD in statistics or biostatistics with relevant experience or MS in
statistics or biostatistics with considerable experience.
Knowledge of clinical study designs, common analysis methods,
descriptive and inferential statistics, and data presentation practices.
Knowledge of the pharmaceutical industry including understanding of
clinical drug development process and documents.
Knowledge of FDA and ICH regulations and industry standards applicable
to the design and analysis of clinical trials.
Good knowledge of statistical programming languages (including SAS),
software, techniques, and processes.
Working knowledge of UNIX operating systems, and common software
products and technologies used in conjunction with
SAS (e.g., Microsoft Office* products).
General project management skills.
Good oral and written communications skills.
Contact:
* Christian Simon - Resource Executive
* Tel: 020 8560 2300
* Send your CV quoting job ref 3445
* AXESS Limited, Parkshot House, 5 Kew Road, Richmond, Surrey.
TW9 2PR
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