Primary Location
: USA-Kansas-Overland Park
Organization
: USA02 - US Clinical Development Svcs
Primary Location
: USA-Kansas-Overland ParkOrganization
: USA02 - US Clinical Development Svcs
Description
This is a homebased opportunity anywhere in North America.
The
Clinical Development Services division of Quintiles has more depth of
therapeutic expertise and a broader range of services than any other
service provider. We conduct both US and Global trials in all
therapeutic areas. In fact, Quintiles conducts more clinical trials than
anyone else in the world. Become involved in work that improves the
quality of life for people around the globe. Let your career soar!
Statistical
Analysts (SAs) blend the roles of statistician and statistical
programmer on the clinical project team. SAs work closely with customer
and Quintiles statisticians on a wide variety of tasks.
RESPONSIBILITIES
· SAs will be responsible for the translation of the SAP into programming specifications for analysis datasets (ADS) and analysis data model (ADaM) datasets
· Will be responsible for reviewing the SAP and the TFL specifications, and to provide feedback to the statisticians
· Provide project deliverable oversight, guidance
and direction to the programming team. This includes guidance in
programming for complex analysis tables/figures, appropriate
procedure/method selection for advance statistical analyses
· Will ensure accuracy, quality, and timeliness of all the work that the programming team does on that project. This
includes conducting comprehensive review of all ADS and TFLs before
final delivery to client. This will be achieved by writing SAS programs
to test key variables within the analysis datasets, and validate key
endpoints and denominators within tables and figures
· You
will work closely with the client and Quintiles project statisticians
to ensure that all project milestones are communicated, tracked, and
delivered within agreed upon planned timelines
Qualifications
· Education Requirements:
o Masters
degree or educational equivalent in Biostatistics (New graduates are
welcome to apply and will be based in our Durham, NC or Overland Park KS
office)
o Masters in related field with 1 year relevant experience;
o Bachelor's in related field with 2 years relevant experience
· Working knowledge of relevant Data Standards (such as CDISC/ADaM)
· Knowledge of statistics and/or clinical drug development process
· Knowledge of statistical computing applications such as Base SAS, SAS/STAT, and SAS Macro Language
· Excellent written and oral communication skills
· Excellent attention and accuracy with details
· Basic
knowledge of applicable clinical research regulatory requirements;
i.e., Good Clinical Practice (GCP) and International Conference on
Harmonization (ICH) guidelines
· Strong individual initiative
· Strong organizing skills
· Strong commitment to quality
· Ability to effectively manage multiple tasks and projects
· Ability to accept direction of lead team members
· Ability to solve moderately complex problems
· Ability to establish and maintain effective working relationships with coworkers, managers and clients
· Have (or be willing to gain) expertise within a therapeutic area, and an understanding of its active compounds and studies
· Good organizational, interpersonal, leadership, communication skills and multi-tasking abilities
see https://quintiles.taleo.net/careersection/10080/jobdetail.ftl
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