Senior Biostatistics Manager - Oncology
Location: Thousand Oaks
Posted on: March 24, 2020
Amgen has a long-term commitment to patients through developing
a new class of novel molecules - and we are looking for the talent
to ensure these molecules become medicines and realize their
potential for helping patients. Amgen's Department of Global
Biostatistical Science (GBS) is at the core of this commitment
through introducing innovative study design and data analysis. The
oncology therapeutic area in GBS has an opportunity for an
experienced biostatistician to join our dynamic team and contribute
to Amgen's commitment to patients worldwide.The Senior
Biostatistics Manager independently leads complex studies and
projects in the oncology therapeutic area, ensuring that the
statistical aspects of clinical activities meet required standards
and are robust and valid. Will also influence and contribute to
strategy development, defend statistical approaches and represent
GBS through participating in and collaborating with
multidisciplinary project teams. Specific duties include:
- Utilizing knowledge and expertise to inform and provide sound
statistical guidance to areas and teams in clinical development,
pediatric filing, marketing support and medical affairs.
- Implementing, managing and supporting standards, technical
quality and consistent approaches in strategy, study design and
- Planning and executing statistical contributions to protocols,
Flash Memos and Clinical Study Reports (CSRs).
- Providing input for clinical publications and regulatory filing
- Overseeing work performed by study statisticians.
- Performing statistical and exploratory analysis of
studies/projects and developing conclusions and
- Anticipating and communicating resource and quality challenges
that could impact deliverables or timelines.
- Working knowledge of regulatory guidelines in oncology drug
- Staying current in developments in the field of statistics in
drug development (innovative trial design) and Amgen's statistical
policies, procedures and strategies.
- Contributing to process improvements and operational
efficiencies.Basic Qualifications Doctorate degree and 2 years of
Biostatistics experienceORMaster's degree and 6 years of
Biostatistics experienceORBachelor's degree and 8 years of
Biostatistics experienceORAssociate's degree and 10 years of
Biostatistics experienceORHigh school diploma / GED and 12 years of
Biostatistics experiencePreferred Qualifications
- Doctorate degree in biostatics or statistics.
- 5 or more years pharma/biotech statistical experience.
- Life cycle drug development experience (pre-clinical, clinical
- Experience with oncology drug development.
- Proven project leadership experience.
- Strong communication and organizational skills.
- Statistical leadership and contribution to regulatory and
- Strong working knowledge of theoretical and applied statistics
and of regulatory guidelines.
- Experience working effectively in a globally dispersed team
environment with cross-cultural partners.Join UsIf 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 patients.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.
Keywords: Amgen, Thousand Oaks , Senior Biostatistics Manager - Oncology, Executive , Thousand Oaks, California
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