SDTM Consultant, Senior Manager

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

SDTM Consultant, Senior Manager

Live

What you will do

Let's do this. Let's change the world. In this vital role you will be accountable and responsible for defining Study Data Tabulation Model strategy for Amgen Global Statistical Programming Department by providing technical expertise and programming leadership to ensure high quality Study Data Tabulation Model project delivery.

Overview:

  • Define Study Data Tabulation Model strategy for Global Statistical Programming
  • Provide Study Data Tabulation Model technical expertise to ensure project deliveries meet regulatory standards for Study Data Tabulation Model
  • Offer Study Data Tabulation Model advice and consultation to Global Statistical Programming and cross-functional teams


Responsibilities:

  • Review of study start up documents such as SAP, CRFs and programming specifications as they pertain to Study Data Tabulation Model study-specific requirements
  • Assess Study Data Tabulation Model datasets and related documents for analysis and regulatory submissions
  • Provide Clinical Data Interchange Standards Consortium expertise and guidance to Global Statistical Programming teams and cross functional partners
  • Offer Clinical Data Interchange Standards Consortium expertise to teams that develop compliant and consistent Clinical Data Interchange Standards Consortium Study Data Tabulation Model datasets, define file and reviewer's guides on time with high quality
  • Promote, adhere to and comment on global and functional standards, processes and methods across all products and studies
  • Evaluate the regular run and disposition of published conformance checks for all snapshots and Study Data Tabulation Model audit for all pivotal snapshots
  • Collaborate with functional service provider (FSP) staff members
  • Participate in the Clinical Data Interchange Standards Consortium Community
  • Assist in study and system audits by internal and external bodies and provide guidance for responses to audit questions and findings.
  • Mentor junior consultants and offer guidance to Global Statistical Programming staff


Win

What we expect of you

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

Basic Qualifications:

  • Doctorate degree and 2 years of relevant experience OR
  • Master's degree and 6 years of relevant experience experience OR
  • Bachelor's degree and 8 years of relevant experience


Preferred Qualifications:

  • MSc or higher degree in quantitative or scientific subjects
  • At least 8 years of relevant statistical programming experience, or equivalent clinical data standards experience, in a clinical development environment
  • Thorough understanding of therapeutic areas (e.g. oncology, respiratory) standards
  • Prior leadership and/or 2 years management experience with projects and people
  • Working experience with external Functional Service Providers
  • Experience working effectively in a globally dispersed team environment with cross-cultural partners
  • In-depth experience creating/working with Study Data Tabulation Model annotations on blank CRF.pdf, reviewers guide, published conformance checks and controlled terminology
  • Comprehensive experience in project management to enable deliverables to be done on time and to a high quality
  • Experience with clinical trial data


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.

careers.amgen.com

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 requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

R-129518