Amgen Biostatistical Programming Senior Manager (Product Lead Programmer) in Thousand Oaks, California
Amgen Global Statistical Programming Department (GSP) is seeking a Biostatistical Programming Senior Manager (Product Lead Programmer) to lead a group of Oncology products. This Senior Manager will be accountable and responsible for GSP study results and submission activities for the assigned product areas.
Set and drive forward the programming strategies, such as, functional standards and industry requirements for the assigned product areas globally
Plan and supervise 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 running 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 as the need arises
Provide mentorship to staff
Provide input into career development plans for all staff on assigned projects
Doctorate degree and 2 years Statistical Programming in Pharmaceutical Industry experience
Master’s degree and 6 years Statistical Programming in Pharmaceutical Industry experience
Bachelor’s degree and 8 years Statistical Programming in Pharmaceutical Industry experience
Associate's degree and 10 years Statistical Programming in Pharmaceutical Industry experience
High school diploma /GED and 12 years Statistical Programming in Pharmaceutical Industry experience
Experience following a formal software development lifecycle
Ability to train others
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
Detailed understanding and experience with data quality and compliance checks (e.g. P21E)
8+ years of relevant statistical programming experience in a clinical development environment
Experience working successfully 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
Sophisticated 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 successfully perform sophisticated statistical programming and related tasks
Experience working on studies of all phases
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.