Biostatistical Programming Manager-SDTM Consultant
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Biostatistical Programming Manager-SDTM ConsultantLive
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 exceed 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.Responsibilities:
- 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:
Masters degree and 3 years clinical trial experience
Bachelors degree and 5 years clinical trial experience
Associate degree and 10 years clinical trial experience
High school diploma and 12 years clinical trial experiencePreferred 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 optimally in a globally dispersed team environment with cross-cultural partners
- Good negotiation skills
Some of the vast rewards of working here
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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual 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. #GDO2021
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.