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 crossfunctional 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 objectoriented programming languages and concepts (i.e. SQL TSQL PL/SQL C#)
Familiarity with Data Reporting Tools: QlikSense QlikView Spotfire Tableau JReview Business Objects Cognos MicroStrategy IBM DataStage Informatica Spark or related
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