Senior Biostatistics Manager - Oncology
About the Job
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
Let’s do this. Let’s change the world. Amgen has a long-term dedication to patients through developing a class of 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 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, pediatric filing, marketing support 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 Amgen’s statistical policies, procedures and strategies.
- Contributing to process improvements and operational efficiencies.
Doctorate degree and 3 years of Biostatistics experience
Master’s degree and 6 years of Biostatistics experience
- Doctorate degree in biostatics or statistics.
- 5 or more years 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.
Some of the vast rewards of working here
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.
- Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
- A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies originality
Objects in your future are closer than they appear. 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 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.