Biostatistical Programming 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.
Biostatistical Programming Senior 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 meeting required standards and are statically accurate.Job Description
Amgen Global Statistical Programming Department (GSP) is seeking a Biostatistical Programming Senior Manager (Product Lead Programmer) to lead a group of products. This Senior Manager will be accountable and responsible for GSP study deliverables and submission activities for the assigned product areas.Responsibilities:
- Accountable and responsible for the Global Statistical Programming (GSP) study deliverables and submission activities for a group of Amgen products;
- Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally;
- Plan and monitor progress of projects and address issues accordingly;
- Support GSP Functional Service Provider (FSP) model and provide oversight for assigned products;
- Provide GSP product level input to developing and managing resource plans and budgets for GSP;
- Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
- Assist in study and system audits by internal and external bodies
- Develop, review and implement Policies, SOPs and other controlled documents affecting GSP globally
- Provide hands-on support to the assigned product areas as required
- Provide coaching and mentoring to staff
- Provide input into career development plans for all staff on assigned projects
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:
- Doctorate degree and 2 years Statistical Programming in Pharmaceutical Industry experience
- Masters degree and 6 years Statistical Programming in Pharmaceutical Industry experience
- Bachelors degree and 8 years Statistical Programming in Pharmaceutical Industry experience
- Familiar with other programming languages (e.g. Java, R, or S-Plus)
- In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL
- Prior regulatory submission experience
- Thorough understanding and experience with data quality and compliance checks (e.g. P21E)
- Experience following a formal software development lifecycle
- Ability to train others
- 8+ years of relevant statistical programming experience in a clinical development environment
- Experience working effectively in a globally dispersed team environment with cross-cultural partners
- Excellent oral and written communication skills
- Good negotiation skills
- Prior staff development leadership and project management experience
- Advanced SAS analysis and reporting skills
- Ability to lead and manage programmers in the successful and timely completion of all programming activities for a study or multiple studies from end to end
- Ability to effectively perform complex statistical programming and related tasks
- Experience working on studies of all phases
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.