SDTM Database Programmer

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.

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.

Essential Functions :

SDTM

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

Elluminate

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

Overall

Ensures data standardization and maintains 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

Requirements / Qualifications :

Associate's degree or higher in information systems, science or related discipline

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