Safety Statistician, Senior Manager (US - Remote)
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. Join us.Safety Statistician, Senior ManagerLive
What you will do
Lets do this. Lets change the world. Amgens Center for Design and Analysis Organization has a new opportunity for a Safety Statistician, Senior Manager to provide independent statistical expertise on safety assessment activities in support of FDA safety reporting requirements. In this vital role, you will independently lead the statistical activities related to the assessment of aggregate safety data for multiple studies/products. You will be part of a cross-functional team, which will provide clinical and statistical judgment to evaluate the totality of the information related to specific adverse events (including different indications, patient populations, study designs, dosing schedules, follow-up durations). You will ensure that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically accurate, influence and contribute to the process development and defend statistical approaches internally and externally. As a Safety Statistician, Senior Manager, you will
- Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams in aggregate safety assessment and reporting.
- Provides statistical expertise on aggregate safety assessment and reporting activities supporting the FDA/IND final rule.
- Authors and provides statistical leadership on aggregated clinical trials safety data analysis plans (ACTSDAP) across multiple studies/products.
- Performs aggregate safety statistical analyses of multiple studies/projects and subsequent exploratory analyses and makes sound conclusions and recommendations.
- Implements, oversees and supports standards, technical quality and consistent approaches in strategy, statistical analysis for safety assessment.
- Anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
- Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines.
- Stays abreast of latest developments in the field of statistics in drug development (innovative trial design), notably in the field of aggregate safety assessment and reporting.
- Adheres to all Amgen Policies, Standard operation procedures (SOPs).
Responsibilities may include:
- Provide statistical expertise to Centralized Statistical Monitoring and Quality Tolerance Limit projects
- Plans and executes statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
- Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
- Oversees statistical work performed by study statisticians.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The statistical professional we seek is a strong with these qualifications.Basic Qualifications:
- Doctorate degree and 2 years of Biostatistics experience Or
- Masters degree and 6 years of Biostatistics experience Or
- Bachelors degree and 8 years of Biostatistics experience
- Technically strong with hands on experience of various design and statistical analysis
- Clinical trial experience
- Any safety assessment experience and/or experience of application of Bayesian methodology in clinical trials environment is a plus
- 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.
careers.amgen.comEqual 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.
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, Puerto Rico and Canada 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.