Background:
Our Client truly is one of the most respected companies in the industry
today. They have a solid pipeline and enviable developing pipeline too.
They deal with the discovery and
development of ethical products in a variety of disease areas. Their
pharmaceutical arm has a European division based in London who can boast
one of the highest staff
retention rates in the industry today. Professional, friendly and
supportive environment. Excellent salary and competitive benefits are
offered for this role.
Primary Duties:
The purpose of this position is to provide program-level statistical
programming expertise by:
* Designing and executing analysis deliverables to meet the
requirements of clinical studies.
* Managing and enforcing standards for derived datasets and
analysis outputs to maximize global data integratability.
* Directing the work of external vendors providing statistical
programming services to achieve quality and timely, cost-effective study
deliverables.
* Represent the statistical programming function in support of
assigned clinical studies and programs lead from the US or EU.
* Define and manage derived data set and reporting standards
* Independently develop, execute, and maintain SAS* computer
programs, including macro programs, according to Statistical Analysis
Plans (SAPs),
cross-study analysis and data specifications or analysis requests
to:
- Produce statistical analysis output (tables, listings and
graphs) to support generation of critical (flash) clinical study
results, cross-study results for investigator brochures,
regulatory submissions, or ad-hoc and exploratory analyses
involving descriptive and simple inferential statistics.
- Perform data manipulations, including creation of derived
data sets, related to the production of the statistical output.
- Verify (QC) study and cross-study analysis results or derived
data sets produced by another TGRD statistical programmer, statistician,
or an external vendor.
* Identify vendor requirements and participate in the
evaluation/selection of BDM vendors. Provide technical oversight of
statistical programming activities of external
vendors to assure timeliness and quality of analysis data and
statistical outputs. Review and approve key statistical programming
vendor deliverables.
* Define and manage transfers of all externally produced
analysis data and outputs.
* Archive statistical outputs and related documentation
according to Company Standards.
Experience and Qualifications:
* Approx 5 years Pharmaceutical experience as a statistician /
Statistical Programmer
* SAS (BASE / STAT / GRAPH)
* Flexible mindset with the ability to show initiative.
Contact:
* Christian Simon - Resource Executive
* Tel: 020 8560 2300
* Send your CV quoting job ref 3684
* AXESS Limited, Parkshot House, 5 Kew Road, Richmond, Surrey.
TW9 2PR
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