Katalyst CRO
SDTM Database Programmer is part of the Data Sciences group and focuses on SDTM programming and custom programming in elluminate, a repository and visualization tool. The role involves developing and maintaining SDTM datasets across multiple clinical studies, and using elluminate to provide the study team with custom objects for data review such as visualizations, graphic patient profiles, and listings.
Responsibilities
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
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
Location: South Plainfield, NJ
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Responsibilities
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
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
Location: South Plainfield, NJ
#J-18808-Ljbffr