Manager, SDTM Development and Operations
- Cambridge, MA
- Employees can work remotely
- Department: Research & Development
- Region: US
The Manager, SDTM Operations is primarily responsible for leading the management of several study SDTM operating activities and deliverables (aCRF, specifications, datasets, define.xml, SDRG, etc). Collaborating cross-functionally within Biometrics, he/she may serve as a leader or provide support in developing and implementing best practices and processes for optimization of the SDTM delivery model. The candidate will review the study pipeline, and serves as a first line for routine day-to-day activities for FSP resources, and review of metrics related to SDTM quality and timelines. This role will ensure quality SDTM package delivery to the Statistical Programming group through oversight of the model.
- Responsible for leading the management of several study SDTM deliverables in accordance with timelines set by project teams and as indicated in the pipeline database.
- Review/create FSP prepared project plans
- Ensures submission compliance
- Consults/Collaborates with study team leads to ensure SDTM expectations are met
- Leads/Participates in SDTM operations meetings for Biometrics
- Contributes to Development, implementation, and maintenance of process documentation and associated templates for SDTM operating activities.
- Contributes to training and education of internal and external resources
- Oversight of vendor/FSP resources workload and quality measurement:
- Serves as first line for in SDTM escalation pathway
- Serves as SDTM SME and participates on Biogen SDTM development team, contributing to best practices and governance requests as appropriate.
- Participates in external teams/forums/conferences to keep abreast of data standards development and regulatory activities
- 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
- Experience working with vendors strongly preferred
- Deep understanding of drug development and biopharmaceutical industry required
- Strong project management skills and ability to effectively lead and collaborate with various business functions
- High attention to detail including proven ability to manage multiple, competing priorities
- Excellent oral and written communication skills
- Demonstrated problem solving and conflict resolutions
- Bachelor’s degree required
All your information will be kept confidential according to EEO guidelines.