Biostatistical Programming Mgr (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.
Biostatistical Programming ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate.
The Statistical Programming Manager will work in Amgen's Biosimilar organization supporting multiple products.
- Represent the product programming function and participate in multidisciplinary project team meetings.
- Collaborate closely with Biosimilar Statisticians and other functional team members.
- Coordinate and oversee the development of dataset specifications and implementation of TLGs according to the statistical analysis plans, work practices, and project timelines in close partnership with CROs in a full-service CRO model.
- Review and approve analysis dataset specifications.
- Review or contribute to data management plans, database development, and edit checks plan.
- Contribute to and review the statistical analysis plans; and results presented in IBs, protocols, clinical study reports, integrated summaries of safety/efficacy, publications, and other documents, as required; provide support and input in protocol development, case report form design, and data collection.
- Ensure that statistical outputs, datasets, and related documentation are archived in a clear, organized, and timely fashion according to company standards.
- Proactively anticipate and communicate resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
- Participate in the review of CRO Policies, SOPs, and other controlled document development.
- Participate in the recruitment of programming staff within Biosimilar organization.
- Contribute to process improvement and operational efficiency.
- Adhere to Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a manager with these qualifications.Basic Qualifications
Masters degree and 3 years of clinical experience
Bachelors degree and 5 years of clinical experiencePreferred Qualifications
Minimum 6 years of relevant career experience in the pharmaceutical or biotechnology industry, with at least a BS degree in Statistics, Life Science, Computer Science, Mathematics, or other relevant scientific subjects; (directly related experience should include the management of people and/or management of drug development projects and/or directing the allocation of programming resources) Knowledge:
- Knowledge of statistical programming within drug development industry, knowledge of drug development process and operation, and drug safety analysis and reporting.
- Experience in the oncology therapeutic area projects is a plus.
- Project management skills - ability to plan and manage projects, to allocate team work on complex tasks, to lead a project successfully from programming set-up to completion and deliver according to agreed timelines.
- Communication skills - the ability to communicate effectively within the team and across functions.
- Statistical programming using the SAS System version 9.1.3 or higher.
- Experience of working within a global team and 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 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
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.
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.