Dear Allstat,
Please find the details for our contract opportunity based in Germany. This
contract is initially for 12 months and paying competitive rates depending
on experience.
If this role is of interest to you please send and updated CV to
[log in to unmask] or alternatively you can contact me on +44
(0)207 922 7126
JOB DESCRIPTION
You will be provide programming support and validation of analysis data
sets, pooled datasets, statistical summary tables, figures and patient data
listings for phase I - phase III clinical trials, ISS & ISE, primarily using
SAS . CDISC knowledge is essential.
RESPONSIBILITIES
Provide output for the Clinical Study Report, the Integrated Summary of
Safety (ISS), the Integrated Summary of Efficacy (ISE) and electronic
submissions.
You will work with biostatisticians and programmers based also in other
sites globally.
This position will require a significant training investment for the use of
client specific processes / procedures in particular, SAS macros, creation
of analysis data sets and dataset structures. Need for ensuring
standardization of programs where applicable.
Apply knowledge of clinical data, the design and phases of clinical trials,
statistics, relevant regulations and the pharmaceutical industry to the
implementation of tasks.
Handle complex statistical programming issues independently and be familiar
with study programming issues. Bring ideas for new projects and take the
initiative to solve issues.
REQUIREMENTS
Statistical SAS programming experience in pharmaceutical related field is
required.
Working knowledge of clinical legislation (FDA, EMEA), Good Clinical
Practice (GCP) and Clinical Data Interchange
Standards Consortium (CDISC).
SAS expert
Fluent in English
Ability to evaluate processes and situations in an orderly and rational
manner asking questions and identifying missing information.
Must be able to determine relationships between different parts of a problem
and identify appropriate solutions.
Accurately and efficiently work towards quality results
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