location_onUnited States,
watch_later Posted: Jul 18, 2024
Skills Required
Nice To Have skills
Job Description
About the job
Company Description
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.
Job Description
REMOTE OPPORTUNITY
About This Role
The Analyst, Study Data Tabulation Model (SDTM) Programmer will be part of the SDTM Development and Operations organization that is evolving and responsible for fulfilling all of Biogen’s SDTM needs with a presence in the United States and Europe.
What You’ll Do
You will lead study-level SDTM programming activities and deliverables (annotated Case Report Form (Acrf), specifications, datasets, define.xml, SDRG, etc.). Collaborating cross-functionally within Analytics and Data Science, you will work other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study. The SDTM Lead will represent SDTM Development and Operations (Dev Ops) in the Biogen Portfolio Disease Unit (DU) discussions. This role will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.
Who You Are
• A Clinical SAS Programmer with some Lead experience
• Someone who is passionate about data, data structures, data transformations and taking/learning about initiatives using Analytics to optimize the transformation of clinical data.
• Experienced in SAS and keen to explore technologies beyond SAS in the clinical trial space.
Qualifications
Required Skills
• Bachelor’s degree or equivalent experience
• 3+ years relevant work experience with a focus on SDTM and statistical programming
• 2-5 years proven data standards experience with a focus on SDTM and end to end data flow
• Pharmaceutical/biotechnology/CRO industry experience
• Good knowledge of clinical data standards, regulatory submission requirements including current global landscape
• Working cross functionally with Biometrics stakeholders
Additional Information
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.
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