SDTM Specialist (Clinical Data Standards Specialist)

Description: The SDTM (Study Data Tabulation Model) Specialist is part of the ACTG and IMPAACT Medidata Rave build teams and assists with the development of CDASH compliant data collection instruments for other projects as needed.

Major duties and responsibilities:

• Assist with development of CDASH compliant data collection instruments 
• Coordinates the annotating, modeling and mapping of the SDTM for assigned studies
• Maintain annotations, modeling specs and mappings throughout the course of the study until submission
• Perform and ensure all QA/QC and validations are complete throughout the CDISC workflow
• Define post-processing requirements for final SDTM deliverables
• Assist with producing any formal data submission package required
• Work directly with the statistician and programmer who is responsible for the ADaM datasets

Reports to: CDISC Coordinator

Controls over position: The SDTM Specialist is assigned to Build Teams and projects by the CDISC Coordinator or the Project PI. The SDTM Specialist will perform duties as defined in study build SOPs or work instructions.

Required qualifications:

• Ability to work in a dynamic, fast-paced research environment
• Comfortable working with and learning a variety of software programs
• Bachelor’s degree or equivalent experience

Preferred qualifications:

• Completion of formal CDASH and SDTM training

With full time employment at Frontier Science, employees are eligible for medical and dental insurance, a generous Paid Time Off (PTO) policy, short term and long term disability, life insurance, participation in a retirement plan, as well as fitness club reimbursement, computer loan assistance, and tuition reimbursement.

Applications will be received through the ADP Workforce Now Career Center using the following link: ADP Workforce Now Frontier Science Career Center.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.