Biostatistics Senior Manager, Oncology (U.S. - Remote)
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.
Biostatistics Senior ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, Global Study Operations (GSO).
The Senior Biostatistics Manager independently leads sophisticated 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 supply 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, reimbursement, and medical affairs.
- Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
- Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs).
- Providing input for clinical publications and regulatory filing documents.
- Leading all aspects of work performed by study statisticians.
- Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations.
- Anticipating and communicating resource and quality challenges that could impact results or timelines.
- Solid understanding of regulatory guidelines in oncology drug development.
- Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgens statistical policies, procedures and strategies.
- Contributing to process improvements and operational efficiencies.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is an emerging leader with these qualifications.Basic Qualifications
- Doctorate degree 2 years of Biostatistics experience OR
- Masters degree and 6 years of Biostatistics experience OR
- Bachelors degree and 8 years of Biostatistics experience
- Doctorate degree in biostatics or statistics.
- 5 or more years of pharma/biotech statistical experience.
- Life cycle drug development experience (pre-clinical, clinical and post-marketing).
- Experience with oncology drug development.
- Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
- Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
- Statistical leadership and contribution to regulatory and reimbursement submissions.
- 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.
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 and well-being.
- Vast opportunities to learn and move up and across our global organization
- 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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
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.
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 requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.