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Operational Statistician
Ref No.: 18-02993
Location: Melvern, Pennsylvania
Position Type:Direct Placement
Start Date: 03/20/2018
At minimum a master's degree in statistics + 8 years' experience in providing statistical support of phase 2/3 trials

Performs sound statistical analyses of clinical trials according to regulatory guidance, SOPs, and guidelines, abreast of pharmaceutical- related statistical literature.
Has completed statistical support for multiple phase 2/3/4 projects
Can effectively lead statistical efforts within a study by writing statistical analysis plans, reviewing analysis dataset specifications, performing quality control of statistical oriented tables, figures and datasets. Can lead a programming team through receiving instructions from clinicians and translating them into analysis requirements. Can author/review sections of clinical study reports. Knowledge of CDISC SDTM/ADaM specifications. This is more of an operational role than it is a leadership role.
Proficient in SAS, R programming skills are "nice to have”. Experience with one or more of the following sample size software packages: NQuery, PASS, EAST
Will not have direct regulatory interaction. However, will support analysis requests stemming from regulatory requests.
Fluent in English, must have effective written and oral communication skills