How will you make an impact?

The Clinical Programmer II will, at the direction of the Lead Clinical Programmers, design clinical study databases, program edit checks, integrate external data sources, and model and deliver data reports, dashboards and datasets. The Clinical Programmer II works in coordination with the Lead Clinical Programmer, Data Management, Biostatistics and Clinical Operation teams to develop standard operating processes in support of clinical research.

What will you do?

Database Design and Programming:

• Develop study database designs (e.g. electronic Case ReportForms) modelling design on CDISC standards.
• Implement a data cleaning strategy (e.g. edit checks, reports, etc.) in accordance to Edit Check Specifications, Data Management Plan, and Data Review Guideline.
• Ensure timely delivery of a quality locked database for analyses at the close of studies.
  Support computer system validation activities

Data Transfer Agreements:

• Create Data Transfer Agreements and manage delivery of third-party clinical data for reconciliation and cleaning.

Collaboration with Cross-Functional Teams:

• Provide ongoing day to day support to the data managers and Clinical Study Teams to ensure all systems and programs are executing correctly and efficiently, to include validating/checking programming.
• Collaborate with internal team and stakeholders to ensure deliverables meettimelines.

Process Improvement:

• Participate in the standardization of libraries for CRFs (modelling CDISC standards) and edit checks to expedite study deliverables
• Recommend technical and process solutions that can be used or developed to increase efficiency of project work

How will you get here?

• Minimum of 2 years of experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Programming or related functional area is required
• Knowledge of FDA/ICH guidelines and industry/technology standard practices
• Experience with any EDC systems platforms (e.g. MedNet, Rave, Veeva Vault EDC etc.)
• Understanding of the clinical trial process
• Experience extracting and transforming clinical data to support Reporting & Analytics
• Knowledge of standards related to Clinical Data Management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.).
• Experience in relational database language such as SQL
• Experience with CDISC (CDASH, SDTM) standards
• Software Development Life Cycle (SDLC) and Computer System Validation (CSV) experience
• Experience with other programming languages such as SAS, R, Python
• Experience with Data Visualization, Reporting or Visual Analytics tools preferred
• Bachelor's degree in computer science, Life Sciences, Biostatistics or equivalent degree