Safety Statistician, Senior Manager
Location: Washington
Posted on: June 23, 2025
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Job Description:
HOW MIGHT YOU DEFY IMAGINATION? If you feel like youre part of
something bigger, its because you are. At Amgen, our shared
missionto serve patientsdrives all that we do. It is key to our
becoming one of the worlds leading biotechnology companies. We are
global collaborators who achieve togetherresearching,
manufacturing, and delivering ever-better products that reach over
10 million patients worldwide. Its time for a career you can be
proud of. Join us. Safety Statistician, Senior Manager Live What
you will do Lets do this. Lets change the world. Amgens Center for
Design and Analysis Organization has a new opportunity for a Safety
Statistician, Senior Manager to provide expertise to our Safety
Assessment Teams and biostatistical colleagues in safety data
analysis . In this vital role, you will lead the statistical
activities related to the assessment of aggregate safety data for
multiple studies/products. You will be part of a cross-functional
team, which will provide clinical and statistical judgment to
evaluate the totality of the information related to ongoing
clinical trials safety assessment. As a Safety Statistician, Senior
Manager, your key activities will include: Represents the
Biostatistics function and participates in multidisciplinary
project team meetings; collaborates closely with other functional
team members; incorporates knowledge of cross-functional areas to
inform and provide sound statistical guidance to teams in safety
assessment. Authors and provides statistical leadership on
aggregated safety analysis plans (ASAP) and safety assessment and
reporting activities across multiple studies/products. Support of
projects related to technical enhancements to support safety
assessment, including data visualizations and decision-making
toolkits. Performs aggregate safety statistical analyses of
multiple studies/projects and subsequent exploratory analyses and
makes sound conclusions and recommendations. Anticipates and
communicates resource and quality issues that may impact
deliverables or timelines within functional area as well as
cross-functionally. Be familiar with statistical policy and
strategy at Amgen; having working knowledge of theoretical and
applied statistics and of regulatory guidelines. Stays abreast of
latest developments in the field of statistics in drug development,
notably in the field of safety assessment and reporting. Adheres to
all Amgen Policies, Standard operation procedures (SOPs). Win What
we expect of you We are all different, yet we all use our unique
contributions to serve patients. The statistical professional we
seek is a strong with these qualifications. Basic Qualifications:
Doctorate degree and 2 years ofstatistical clinical trial
experience Masters degree and 4 years of statistical clinical trial
experience OR Bachelors degree and 6 years ofstatistical clinical
trial experience OR Associates degree and 10 years ofstatistical
clinical trial experience OR High school diploma / GED and 12 years
of statistical clinical trial experience Preferred Qualifications:
Technically strong with hands on experience of various design and
statistical analysis Clinical trial experience Any safety
assessment experience and/or experience of application of Bayesian
methodology in clinical trials environment is a plus Experience
working effectively in a globally dispersed team environment with
cross-cultural partners Proficiency in developing or supervising
the development of data visualization tools and data analysis
applications using eg. R/Shiny is highly desirable 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 plan Stock-based long-term
incentives Award-winning time-off plans and bi-annual company-wide
shutdowns Flexible work models, including remote work arrangements,
where possible Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com In any materials you submit, you may redact or
remove age-identifying information such as age, date of birth, or
dates of school attendance or graduation. You will not be penalized
for redacting or removing this information. Application deadline
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. As an organization
dedicated to improving the quality of life for people around the
world, Amgen fosters an inclusive environment of diverse, ethical,
committed and highly accomplished people who respect each other and
live the Amgen values to continue advancing science to serve
patients. Together, we compete in the fight against serious
disease. Amgen is an Equal Opportunity employer and will consider
all qualified applicants for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, protected veteran status, disability status, or any other
basis protected by applicable law. 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. 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.
Keywords: , Arlington , Safety Statistician, Senior Manager, Science, Research & Development , Washington, Virginia