We are currently seeking 3 statistical programmers for our biotechnology
clients based in the Bay Area (San Francisco) California.
You will provide programming support for completion of Item 11 for
electronic submission of drug candidate, validation of CRO’s analyses of
front line results for two Phase 3 clinical trials, and development of
processes and templates for the production of summary tables and data
listings in a timely and efficient manner. You will process clinical data
required for analysis of clinical trials for Phase 1-3 studies. Develop SAS
coding and table templates for preparing, processing and analyzing clinical
data in a timely manner consistent with SOPs and guidelines. You will
provide programming support for validation of clinical trial databases.
Interact with members of in-house study teams, biometrics staff and CRO
teams. And provide support for completion of Item 11 for use in
e-submission.
In order to be considered you should have a Bachelor’s degree or equivalent
in statistics, biostatistics, mathematics or computer science. Master’s
degree in statistics, biostatistics, or computer science preferred. You
should also have at least 5 years of relevant programming experiences in
biotech or pharmaceutical industry, including experiences in multiple
therapeutic areas and in various phases of drug development.
Ideally you will have experience in supporting regulatory submissions. In
particular, experience with electronic submissions and support of Item 11 is
desired. You should have Exceptional knowledge of the structure of clinical
data and extensive experience in programming clinical data using SAS is
required.
Extensive knowledge of SAS/Base, SAS/Macro, SAS/Graph, SAS/Stat and the
ability to write maintainable, supportable and well-documented SAS code is
essential. Experience in Windows SAS is desirable.
If you do not quite have all the skills listed above, but are interested in
working in California please contact for general discussion.
Suzannah Austen-Adams
Bioinsource
Calling From:
UK: 0845 634 0505
Europe: + 44 1666 840 323
USA:1 888 602 1864
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