Sdtm Lead

**Job Description**:
The SDTM Lead, SDTM Development and Operations is primarily responsible for leading/programming study SDTM operating activities and deliverables (aCRF, specifications, datasets, define.xml, SDRG, etc.). Collaborating cross-functionally within Biometrics, he/she will work other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study. This role will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.

**Qualifications**:

- Bachelor’s degree required
- 3-5 years relevant work experience with a focus on SDTM, statistical programming, data analysis, vendor management
- SAS programming skills required
- Understanding of SDTM data structures required
- 2-5 years proven data standards experience with a focus on SDTM and end to end data flow
- Strong knowledge of clinical data standards, regulatory submission requirements including current global landscape
- Good understanding of drug development and biopharmaceutical industry required
- Strong project management skills and ability to effectively lead and collaborate with various business functions

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.