Address
Form of work
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.
Biostatistical Programming Senior Manager
Live
What you will do
Lets do this. Lets change the world. In this vital role you will work in Amgen's Biosimilar organization supporting multiple products.
Responsibilities
Represent the product programming function and participate in multidisciplinary project team meetings.
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, including the review and analysis dataset specifications approval.
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.
Operational effectiveness, Recommendations for Program Level Consistency and Submission Readiness including data standards.
Work with CRO and Amgen team to put together the submission data packages.
Lead and/or contribute to the technical solutions to implement CRO programs on Amgen system and perform ad-hoc analysis to support submission and publications need.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of statistical programming experience in a clinical development environment OR
Masters degree and 4 years of statistical programming experience in a clinical development environment OR
Bachelors degree and 6 years of statistical programming experience in a clinical development environment OR
Associates degree and 10 years of statistical programming experience in a clinical development environment OR
High school diploma / GED and 12 years of statistical programming experience in a clinical development environment
Preferred Qualifications:
MSc or higher degree in quantitative or scientific subjects
Familiarity with other programming languages (e.g. Java, R)
In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL
Regulatory submissions experience
Thorough understanding and experience with data quality and compliance checks, e.g., Pinnacle21
Experience of working within a global team and CRO partners to ensure operational excellence and efficiencies.
Prior staff development and project management experience
Ability to train others
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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 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.
