At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we’re changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients’ lives and on changing the course of medicine.   

About This Role

As the Principal/Sr. Principal, you will be part of the Study Data Tabulation Model (SDTM) Development and Operations organization that is evolving and responsible for fulfilling all of Biogen’s SDTM needs with presence in the Unites States and Europe.

What You’ll Do

You will manage several study SDTM operating activities and deliverables and work cross functionally in Biometrics to lead/support in developing & implementing best practices and processes. You will review the study pipeline and serve as a first line for routine day-to-day activities for Functional Service Provider (FSP) resources, and review of metrics related to SDTM quality and timelines.

Who You Are

You are a Clinical Programmer with Lead experience who wants to manage FSP globally.  You are passionate about data, data structures, data transformations and taking/learning about initiatives using Analytics to optimize the transformation of clinical data.  You are experienced in SAS and are keen to explore technologies beyond SAS in the clinical trial space.

Required Skills

• Bachelor’s degree
• 5+ years relevant work experience with a focus on SDTM, statistical programming, data analysis, vendor management space
• 2-5 years proven data standards experience with a focus on SDTM and end to end data flow
• 5 + years of SAS experience
• Strong knowledge of clinical data standards, regulatory submission requirements including current global landscape
• Experience working with vendors
• Strong project management skills and ability to effectively lead and collaborate with various business functions
• Demonstrated problem solving and conflict resolutions

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

All your information will be kept confidential according to EEO guidelines.