CONTRACT: 3x Senior Statistical Programmers
ISE & ISS Specialists
6 month Benelux based role + extensions
Job Summary:
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
(Primarily Phase 1 at least in the beginning).
Accountabilities/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.
Essential Skills & Capabilities:
At least 3-4 years Statistical SAS programming experience with prior
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) is
a plus.
* SAS expert
* Fluent in English (French is an asset)
* 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
An excellent opportunity awaits for this renewable contract. Interview times
booked and full job specification to review...
If you would to discuss this role in greater detail or your application /
suitability to this or further roles, please call me or email me in
confidence. If you are not available or suited to this position, please feel
free to pass my details on.
We also have a broad variety of other Biometric specific vacancies available
in the UK and throughout Europe. Inclusive of SAS programming, Statistical,
Clinical programming, Data Management functions, Regulatory Affairs,
Clinical Research, QA, Compliance & Validation.
For a confidential consultation call James Carrera on 0044 (0) 207 255 6665
or email your CV to [log in to unmask]
James Carrera
European Contracts Manager
Pharmaceutical, Healthcare & CRO division
1st Pharma People
"A Division of 1st IT People"
Tel: +44 (0) 207 255 6665
Mobile: +44 7717 578 246
Fax: +44 (0) 207 255 6656
mailto:[log in to unmask]
www.1st-pharmapeople.com
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