Career Category

Clinical

Job Description

Amgen Global Statistical Programming Department (GSP) is seeking a Biostatistical Programming Senior Manager (Product Lead Programmer) to lead a group of General Medicine 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 General Medicine 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) relationship and oversight; Ensure the product goals can be met via the FSP staff.

Provide GSP product level input to developing and managing resource plans and budgets for GSP.

Efficiently and effectively monitor and utilize assigned staff at product level according to priorities.

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.

Basic Qualifications:

Doctorate degree and 2 years  Statistical Programming in Pharmaceutical Industry experience
OR
Master’s degree and 6 years  Statistical Programming in Pharmaceutical Industry experience
OR
Bachelor’s degree and 8 years Statistical Programming in Pharmaceutical Industry experience

OR

Associate’s degree and 10 years Statistical Programming in Pharmaceutical Industry experience

OR

High school diploma and 12 years Statistical Programming in Pharmaceutical Industry experience
 

Preferred Qualifications:             

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

Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating and executing test plans).

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

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.

Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.

Join Us

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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.