Senior Statistician - London Based Pharmaceutical
Call 0207 255 66 00 for a confidential discussion and full details..
Appointment Details:
The purpose of this appointment is to provide program-level statistical
expertise:
* Designing, analysing and interpreting clinical studies and programs.
* Standardizing study design, analysis methodology and presentations
to maximise global data Integratability.
* Leveraging external vendors providing statistical services to
achieve quality, timely, cost-effective study deliverables.
The main role responsibilities are to:
* 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 defence 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. Escalate
issues to management as appropriate.
* Contribute to increasing efficiency of the Statistics function
through development of standard analysis methodology, data presentations and
sharing of best practices. Support implementation of such standards and
process improvements.
* Comply with all applicable regulatory requirements, internal
standards and procedures.
What are we looking for?
To secure this role you will be PhD qualified with 2 years relevant
experience or MSc qualified with 3+ years relevant experience. Your
experience can be gained from a Pharmaceutical, CRO, Biotech or academic
posts.
You will combine the above with:
* 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
* General project management skills.
* Good oral and written communications skills.
Rewards
Our client places great emphasis on the development of its people and
consistently ensures that they are rewarded for their endeavour. You will
receive an excellent starting salary for this position in comparison to
equivalent positions across the UK. Benefits are comprehensive, including
annual bonus. Personal and professional development is continuous. This
position offers the opportunity for international travel. Full details are
available on application.
For further information call Alan Brophy on 0207 255 66 00. To make an
application forward your CV with a short cover note to
[log in to unmask] <mailto:[log in to unmask]>
Kind regards,
Alan
Alan Brophy
SEC Recruitment, London
Tel: 0207 255 66 00
Fax: 0207 255 66 01
alan.brophy@sec <mailto:[log in to unmask]> pharma.com
SEC are an ISO9001:2000 accredited specialist recruitment company working
within the Pharmaceutical, Biotech and CRO industries. If you are interested
to learn more about further appointments within Biostatistics or Statistical
Programming across the UK and Mainland Europe contact Alan on 020 7 255 6600
for a confidential discussion.
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