Senior CDM Programming Specialist

IDDI (International Drug Development Institute), a Statistical and eClinical services provider in the field of clinical research is looking to fill the following position for its Clinical Data Management department in Raleigh (US):   

Senior CDM Programming Specialist

Reporting to the Manager, Clinical Data Management, you will be responsible for the development of SAS programs required to perform Clinical Data Management activities: reporting, cleaning, coding, reconciliation plus generation of SDTM datasets.

Responsibilities:

  • Collaborate with Clinical Data Management and Statistical team members to ensure programming requirements are fulfilled per timelines.
  • Program the SAS data validation listings and reports for data cleaning tasks e.g. reconciliation and manual data review
  • Develop the SAS programs required for other data management tasks such as coding of medical data, importing of external vendor data, and unblinding of database at database lock.
  • Program reports to report clinical data and/or trial progress reports for clinical operations personnel or trial metrics for clinical data managers to assist in trial oversight and management
  • Independently develop the specifications (annotated CRF) and Program the associated SDTM datasets. Once Quality Control is complete liaise with personnel to correct/amend findings until all issues are resolved and SDTM is ready for production.
  • Independently generate all SDTM deliverables to be fully FDA submission compliant
  • Create all dashboard reports
  • Support the generation of dashboard reporting standards

Profile:

  • At least a Bachelor’s degree in scientific field plus 8 years experience
  • Extensive (at least 8 years) SAS programming experience
  • Extensive (at least 5 years) CDISC SDTM experience required
  • Experience in clinical research and particularly Clinical Data Management
  • The successful candidate must have good written and oral communication, organizational, planning and interpersonal skills

We offer a permanent position in an innovative and dynamic company. 

Please send your CV and cover letter to IDDI by e-mail at careersusa@IDDI.co

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