Job Description
About This Role
The 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 presence in the United States and Europe.
What You’ll Do
You will lead study level Study Data Tabulation Model (SDTM) programming activities and deliverables (aCRF, specifications, datasets, define.xml, SDRG, etc). Collaborating cross-functionally within ADS, he/she 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 Dev&Ops in the Biogen Portfolio DU discussions. This role will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.
Qualifications
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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.
Required Skills
· Bachelor's degree
· 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
· 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.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.