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Biostatistics Manager - Washington D.C., United States - Amgen
Description
Biostatistics ManagerWHAT YOU WILL DO
Lets do this. Lets change the world.
In this vital role you will achieve results through detailed goalsetting, accountability measures, effective partnership, performance management, collaborationwith other groups and a dedication to serving customers, both inside and outside of, CfDA (Centerfor Design & Analysis).
The Biostatistics Manager independently leads sophisticated studies in theGeneral Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, andNeuroscience), ensuring that the statistical aspects of clinical activities meet required standards andare robust and valid.
Will also influence and supply to strategy development, defend statisticalapproaches and represent GBS (Global Biostatical Science) through participating in andcollaborating with multidisciplinary study teams.
WIN
WHAT WE EXPECT OF YOU
We are all different, yet we all use our outstanding contributions to serve patients. The professionalwe seek is proficient with these qualifications.
Key activities include:
Providing statistical contributions, statistical review, and quality control of Key DesignElements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs),Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key study related documentation, protocol deviations, Flash Memos, Clinical Study Reports(CSRs), clinical publications, and other communications
Completing statistical analysis of individual studies/projects
Publishing applied research in scientific journals and books, and give presentations onstatistical methodology in the biopharmaceutical setting at external scientific meetings(biopharmaceutical industry and academic meetings)
Being familiar with statistical policy and strategy at Amgen
Staying abreast of the latest developments in the field of statistics in drug development andcontribute to scientific advances in the field
Communicating the role of the Global Biostatistics department, and may contribute tostatistical training within Global Biostatistics and within Amgen
Assisting in the review of Amgen Policies, SOPs, and other controlled documents
Assisting with study and systems audits conducted by Amgen CQA and external bodies
Serving as team member of change / process improvement initiatives
BASIC QUALIFICATIONS:
Doctorate degree OR Masters degree and 3 years of experience OR
Bachelors degree and 5 years ofexperience OR Associates degree and 10 years of experience OR High school diploma / GED and 12 years ofexperience
PREFERRED QUALIFICATIONS:
Doctorate degree in statistics or biostatistics
