Clinical Database Programmer

OVERVIEW

The Clinical Programmer is responsible for developing and maintaining clinical trial programming, ensuring data integrity, and supporting data analysis for clinical studies. The role involves working closely with biostatisticians, clinical data managers, clients and other stakeholders to ensure that all programming tasks are executed accurately and efficiently across all Biometrics Services projects. The Clinical Programmer is accountable for quality, timely and efficient delivery of project programming tasks and quality information management.

KEY TASKS & RESPONSIBILITIES

• Read and understand clinical study protocols to better understand the programming needs for a specific trial
• Develop and build basic components of clinical databases, including forms and structure, data dictionaries and unit dictionaries
• Program a range of simple to complex validations to support validation of the clinical data
• Collaborate with cross-functional team members (i.e. Data Managers, Biostatisticians, Coders, etc) and clients to review the business requirements and translate them into database objects and visualizations
• Design, develop, test, and deploy highly efficient SQL code and data mapping code according to specifications
• Develop and support rigorous QC processes to ensure quality of data deliverables.
• Develop ETL code in support of analytic software applications and related analysis projects
• Build any analytics reports and visualizations using tools like JReview, Qlik
• Provide diagnostic support and fix defects as needed
• Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures
• Other duties as assigned

CANDIDATE S PROFILE

Education & Experience

• Bachelor s degree and/or equivalent work experience preferred
• 5+ years in Pharmaceutical/Biotechnology industry or equivalent preferred
• Familiarity with EDC Systems: Rave, InForm, or Veeva preferred; previous experience designing eCRFs and edit checks
• Knowledge of clinical trial data is a plus - CDISC ODM, SDTM, or ADAM standards
• Experience developing back end, database/warehouse architecture, design and development preferred
• Knowledge of variety of data platforms including SQL Server, DB2, Teradata, (Cloud based DB a plus)

Professional Skills

• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent knowledge of English; verbal and written communication skills
• Proficiency in clinical protocol interpretation and application
• Excellent team player
• Good understanding of technical challenges and capability to analyze requirement and technical problems
• Excited to learn new tools and product modules and adapt to changing technology and requirements

Technical Skills

• Proficiency in Microsoft Office 365 Suite including Excel, Word, and Outlook
• Experience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards (CDASH, SDTM) preferred
• Familiarity and/or proficiency with database platforms
• Preferred experience in object-oriented programming languages and concepts (i.e. SQL, T-SQL, PL/SQL, C#)
• Familiarity with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related