Clinical Database Programmer

Summary

• The SDTM Database Programmer is part of the Data Sciences group and is focused on SDTM programming and custom programming in elluminate, a repository and visualization tool.
• The SDTM Database Programmer is responsible for the development and maintenance of SDTM datasets on multiple clinical studies. The programmer will also work with elluminate software to provide the study team custom objects for data review, such as visualizations, graphic patient profiles, and listings.
• This role combines knowledge of clinical data standards with technical skills to perform data mapping, programming, validation, and administration within the SAS and elluminate environments. This is a first-in-role position at Ironwood.

Essential Functions:

• Annotate CRFs in accordance with CDISC published or program specific guidelines
• Craft SDTM dataset specifications
• Program and validate SDTM datasets in SAS and/or elluminate
• Participate in the quality assurance of vendor developed SDTM datasets and documentation
• Participate in the review of eCRFs and collection tools
• Participate in the review of data transfer specifications as it relates to data flow for the study
• Liaise with study team members and develop custom objects in elluminate
• Utilize the Mapper module and T-SQL programming to develop custom datasets
• Develop at least a subset of SDTM datasets within elluminate
• Ensure documentation and validation of objects are timely and complete
• Participate in the testing of elluminate upgrades and documenting test scripts
• Ensures data standardization and maintains Ironwood data model across studies
• Contributes to quality system requirements for clinical data programming ( e.g., review and/or develop SOPs)
• Promotes enduring relationships regarding datasets and data transfers with study team members, CROs, third party data vendors, and EDC vendors
• Maintains current knowledge of and ensures all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory, GxP requirements and related policies and procedures. Advocates for full legal compliance and ethical conduct in all business transactions.
• Duties, responsibilities, and activities may change, or new ones may be assigned as business and organizational requirements evolve.

Requirements:

• Ideal candidate would have 4+ years of experience in SDTM programming
• Ideal candidate would have experience with elluminate or a dynamic visualization tool
• Proven SQL & SAS programming experience
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
• Experience with CDISC® related data models like SDTM, and ADAM
• Knowledge of medical coding dictionaries (WHODrug, MedDRA)
• Ability and willingness to learn new technologies
• Excellent team player with strong verbal and written communication skills
• Associate's degree or higher in information systems, science or related discipline