Biostatistics Sr Manager
Location: Washington
Posted on: June 23, 2025
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Job Description:
Join Amgens Mission of Serving Patients At Amgen, if you feel
like youre part of something bigger, its because you are. Our
shared missionto serve patients living with serious illnessesdrives
all that we do. Since 1980, weve helped pioneer the world of
biotech in our fight against the worlds toughest diseases. With our
focus on four therapeutic areas Oncology, Inflammation, General
Medicine, and Rare Disease we reach millions of patients each year.
As a member of the Amgen team, youll help make a lasting impact on
the lives of patients as we research, manufacture, and deliver
innovative medicines to help people live longer, fuller happier
lives. Our award-winning culture is collaborative, innovative, and
science based. If you have a passion for challenges and the
opportunities that lay within them, youll thrive as part of the
Amgen team. Join us and transform the lives of patients while
transforming your career. Biostatistics Sr Manager What you will do
Lets do this. Lets change the world. In this vital role you will
provide statistical support for multiple clinical studies across
all phases of clinical development. Apply statistical principles
and techniques to a wide range of problems within the clinical
development environment with the supervision of more senior staff.
Accountabilities Provide dedicated support for Exploratory
Biostatistics Execute key projects, deliverables and operational
tasks related to exploratory biostatistical strategy, technical
expertise, and reporting within designated studies / products
Execute statistics strategy, implement standards and approaches to
ensure quality and technical excellence in strategy, exploratory
analysis planning, and statistical analyses Advise and manage
statisticians on best practices and techniques for exploratory
analysis to align with industry standards and to provide valid,
robust conclusions Opportunity to serve as the product or disease
area exploratory analysis lead, as needed Responsibilities
Statistical Excellence Utilize knowledge and expertise to inform
and provide sound statistical guidance to areas and teams in
clinical development, clinical trial biomarker (CTA) and companion
diagnostics (CDx) co-development, and precision Medicine
organization. Plan and execute statistical activities contributing
to exploratory statistical analysis plans, reports and publications
Implement, manage and support standards, technical quality and
consistent approaches in strategy, study design and statistical
analysis. Knowledgeable of developments in the field of statistics
in drug development (innovative trial design) and Amgens
statistical policies, procedures and strategies. Understand,
promote, and communicate innovative and standard statistical
methodologies, trial design, data analysis, and medical / clinical
understanding for product Oversee statistical contributions to
statistical analysis plans, tables, figures and listing shells,
submission data file specifications, and other key study-related
documentation Collaborate cross-functionally to deliver robust,
valid and scientifically rigorous analysis results in Table, Figure
and Listings (TFLs), Flash Memos (FM), Clinical Study Reports
(CSRs), clinical publications, and other communications Serve as
the EBG lead on the Evidence Generation Team (EGT) or Clinical
Study Team (CST) with exploratory analysis needs to support
Precision Medicine or drug/CDx codevelopment Contribute to clinical
publications, regulatory filing documents, reimbursement documents
and other communications for product or study Provide statistical
consultancy, training, and advice within Amgen Contribute to
process improvement initiatives and operational efficiencies
Oversee FSP statisticians and check their contributions for quality
Opportunity to manage staff, e.g.external contractors Opportunity
to serve as a product or disease area exploratory analysis
biostatistical lead to support Precision Medicine What we expect of
you We are all different, yet we all use our unique contributions
to serve patients. The dynamic professional we seek is a leader
with these qualifications. Basic Qualifications: Doctorate degree
and 2 years of industry experience in biostatistics, mathematics,
physics, and related quantitative fields OR Masters degree and 4
years of industry experience in biostatistics, mathematics,
physics, and related quantitative fields OR Bachelors degree and 6
years of industry experience in biostatistics, mathematics,
physics, and related quantitative fields OR Associates degree and
10 years of industry experience in biostatistics, mathematics,
physics, and related quantitative fields OR High school diploma /
GED and 12 years of industry experience in biostatistics,
mathematics, physics, and related quantitative fields Preferred
Qualifications: Doctorate degree in biostatistics, mathematics,
physics, and related quantitative fields and at least 4 years of
post-graduate statistical or data science experience Or Masters
degree in biostatistics and at least 8 years of post-graduate
statistical and data analysis experience in the pharmaceutical
industry or medical research Life Cycle Drug Development Experience
(Pre-clinical Development, Clinical Development, and
Post-marketing) Experience in Inflammation therapeutic area
clinical development Strong verbal and written communication
combined with organizational skills and cross-cultural sensitivity
Statistical leadership and contribution to regulatory and
reimbursement submissions. of regulatory guidelines. Experience
working effectively in a globally dispersed team environment with
cross-cultural partners. What you can expect of us As we work to
develop treatments that take care of others, we also work to care
for your professional and personal growth and well-being. From our
competitive benefits to our collaborative culture, well support
your journey every step of the way. The expected annual salary
range for this role in the U.S. (excluding Puerto Rico) is posted.
Actual salary will vary based on several factors including but not
limited to, relevant skills, experience, and qualifications. In
addition to the base salary, Amgen offers a Total Rewards Plan,
based on eligibility, comprising of 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 that may include: A 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
Flexible work models, including remote and hybrid 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.
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