Biostatistical Programming Senior Manager

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 Manager

Live

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.

Amgen Global Statistical Programming Department (GSP) is seeking a Biostatistical Programming Senior Manager (Product Lead Programmer) to lead a group of General Medicine or Oncology 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) 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.

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 proficient with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years Statistical Programming in Pharmaceutical Industry experience Or

Masters degree and 6 years Statistical Programming in Pharmaceutical Industry experience Or

Bachelors degree and 8 years Statistical Programming in Pharmaceutical Industry experience Or

Associate 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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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.

Thrive

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

Apply now

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.

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Equal 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 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.