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Biostatistics Manager

3 months ago

Washington, Washington, D.C., United States Amgen Full time

Biostatistics Manager
WHAT 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

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.