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Biostatistical Programming- SDTM, Manager

Thousand Oaks, CA
Start date
May 12, 2023

Job Details


Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Biostatistical Programming SDTM, Manager


What you will do

Lets do this. Lets change the world. In this vital role you will be 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 demonstrates its expertise to strive for solutions that improve health outcomes and spectacularly 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.

The CDISC Consultant Group (CCG) within Global Statistical Programming helps to align Amgen with changing SDTM CDISC standards and serves as an interface between CDISC and Amgen.

SDTM Consultants within CCG work with Biomedical Data Stewardship (BMDS) to align Data Element Standards (DES) with CDISC standards where possible and to provide clear guidance where DES exceeds the scope of current CDISC standards.

SDTM Consultants also work with GSO-DM to review global edit-check content related to SDTM submission conformance checks. In addition, SDTM Consultants work with product teams to help in their implementation of DES and CDISC standards for SDTM data sets.

SDTM Consultants also work with SPS to help develop useful macros for SDTM programming and support (e.g., bookmark wizard, date imputation, etc.). Finally, SDTM Consultants, and CCG as a whole, look beyond individual product teams needs to ensure that GSPs implementation of SDTM meets all downstream customer needs (e.g., TransCelerate, TRIP, etc.), in addition to meeting basic analysis and submission requirements.

  • Reviewing of study start up documents such as SAP, CRFs and programming specifications

  • Review SDTM datasets and related documents for analysis and regulatory submissions

  • Provide CDISC expertise and mentorship to GSP teams and cross functional partners

  • Adherence to Amgen Policies, SOPs and required industry standards for product-level results

  • Supports global standards level content management and impact analysis (e.g., SDTM templates, metadata, SDTM-IG versions)

  • Support cross-functional development of global standard, TA, and/or product-level CRFs

  • Lead Amgen SDTM knowledge base


What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an emerging leader with these qualifications.

Basic Qualifications:

Doctorate degree OR Masters degree and 3 years clinical trial experience OR Bachelors degree and 5 years clinical trial experience OR Associate degree and 10 years clinical trial experience OR High school diploma and 12 years clinical trial experience

Preferred Qualifications:

  • Masters degree in quantitative or scientific subjects

  • Detailed understanding of TA (e.g., oncology, respiratory) standards

  • Working experience with external staffing providers

  • Ability to train others

  • 4+years of relevant statistical programming experience in a clinical development environment

  • Experience working successfully in a globally dispersed team with cross-cultural partners

  • Good negotiation skills

ThriveWhat 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.

This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is $121,844 - $135,382.

In addition to the base salary, 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.

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 cancers, 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.


We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.


Find Us
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks

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