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.
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
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