Biostatistics Director, Oncology Biosimilars- US Remote
Location: Washington
Posted on: June 23, 2025
|
|
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. Biostatistics Director Live What you will do Lets do
this. Lets change the world. In this vital role, you will provide
strategic statistical input and be responsible for all statistical
aspects of clinical development from early to late phase for
multiple products across different therapeutic areas. Key
Responsibilities include: Lead Statistical excellence in the
design, analysis and reporting for all phases of clinical
development across multiple products and therapeutic areas
including strategic statistical input and contributing to clinical
development plans. Reviews product and study level documents such
as clinical development plans, regulatory documents, study
synopses, protocols, statistical analysis plans (SAPs), flash
memos, clinical study reports (CSRs), submission documents,
correspondences with health authorities, and clinical publications
Statistical leadership to regulatory submissions Developing and
execution of statistical strategy for clinical development programs
ensuring standards, technical quality and consistent approaches in
clinical development strategy, study design and statistical
analysis while maintaining indication specific standards with
respect to key variables, variable definitions, statistical
methods, data structures and presentation of results. Ensuring
excellent statistical input into regulatory strategies,
presentations and scientific reports for clinical trial, regulatory
submission, product defense, market support, scientific
presentations/publications. Representing the statistical function
at meetings with regulatory authorities, key opinion leaders and
other specialist bodies and defending statistical approaches.
Providing oversight and mentorship to Amgen staff members and CROs
in completing study deliverables per agreed to timelines and
quality standards. Supporting the development and review of
Policies, SOPs and other controlled documents with CROs or within
Amgen for process improvement and operational efficiency. Providing
subject matter expertise in statistical methodologies, publishing
applied research in scientific journals and books and making
presentations on statistical methodology in the biopharmaceutical
setting at external scientific meetings. Staying abreast of and
contributing to scientific advances in the field and ensuring
internal practices are current. Developing and maintaining
long-term relationships with key statistical opinion leaders within
academics, regulatory agencies and industry. Oversee
biostatisticians in Contract Research Organizations (CROs), lead,
manage and develop in-house statistical staff, and assist Amgens
head of Biosimilar Biostatistics and Statistical Programming guide
the department. Win What we expect of you We are all different, yet
we all use our unique contributions to serve patients. The
Biostatistics Director we seek is a project leader with these
qualifications: Basic Qualifications: Doctorate degree and 4 years
of Biostatistics experience OR Masters degree and 8 years of
Biostatistics experience OR Bachelors degree and 10 years of
Biostatistics experience Knowledgeable of statistical methodology
and applications within drug development, including oncology
clinical trials Preferred Qualifications: Master's or Doctorate
degree in Mathematics, Biostatistics or Statistics Ten years
post-graduate statistical experience in the pharmaceutical industry
or medical research organizations with a deep knowledge of
statistical methodology and applications within drug development,
especially in the oncology therapeutic area Statistical leadership
to regulatory submissions Effective communication and presentation
skills including statistical strategy (written and oral)
Demonstrated ability to drive innovation by implementing new
methodologies and relevant statistical designs Experience in
statistical methodologies related to adaptive designs (e.g., group
sequential design, adaptations to treatment arm selection design,
Bayesian adaptive design), combined phase 1/2 or phase 2/3 design,
or Bayesian analyses Life cycle Drug development experience
(pre-clinical development, clinical development, post-marketing)
Demonstrated leadership attributes with a track record in charting
the course and developing high-performance teams Experience of
working within a global team and with CRO partners to ensure
operational excellence and efficiencies 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. The annual base salary range for this
opportunity in the U.S. is $186,729 - $213,551. In addition to the
base salary, 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
Keywords: , Arlington , Biostatistics Director, Oncology Biosimilars- US Remote, Science, Research & Development , Washington, Virginia