HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because
you are. At Amgen our shared mission-to serve patients-drives all
that we do. It is key to our becoming one of the world's leading
biotechnology companies. We are global collaborators who achieve
together-researching, manufacturing and delivering ever-better
products that read over 10 million patients worldwide. It's time
for a career you can be proud of. Join us.
What you will do
Let's do this. Let's change the world. In this vital role, you
will provide strategic statistical input and oversee 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
Ensuring excellent statistical input into regulatory strategies,
presentations and scientific reports for clinical trial, regulatory
submission, product defense, market support, scientific
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
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
- Oversee biostatisticians in Contract Research Organizations
(CROs), lead, manage and develop in-house statistical staff, and
assist Amgen's head of Biosimilar Biostatistics and Statistical
Programming guide the department.
What we expect of you
We are all different, yet we all use our outstanding
contributions. The Biostatistics professional we seek is a project
leader with these qualifications.
Masters or Doctoral degree in Statistics/Biostatistics or other
subject with high statistical content, and 8 years of post-graduate
statistical experience in the pharmaceutical industry or medical
Knowledgeable of statistical methodology and applications within
Statistical leadership to regulatory submissions
- Demonstrated effective communication and presentation skills
including statistical strategy
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.
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) and/or combined
phase 1/2 or phase 2/3 design.
Statistical leadership for regulatory submissions.
Demonstrated effective communication and presentation skills
including statistical strategy (written and oral).
Life cycle Drug development experience (pre-clinical
development, clinical development, post-marketing).
Demonstrated leadership attributes with a proven track record in
charting the course and developing high-performance teams.
- Proven background in working within a global team and with CRO
partners to ensure operational excellence and efficiencies.
What you can expect of us
As we work to develop treatments that take care of others, so we
work to care for our teammates' professional and personal growth
Vast opportunities to learn and move up and across our global
Diverse and inclusive community of belonging, where teammates
are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and
wealth, work/life balance, and career benefits
Apply now for a career that defies imagination
In our quest to serve patients above all else, Amgen is the
first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
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 a
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 an accommodation.
If you're seeking a career where you can truly make a difference
in the lives of others, a career where you can work at the absolute
forefront of biotechnology with the top minds in the field, you'll
find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers
innovative human therapeutics. Our medicines have helped millions
of patients in the fight against cancer, kidney disease, rheumatoid
arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live
the Amgen values as we continue advancing science to serve
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, or disability status.