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Job Function:
Data Analytics & Computational SciencesJob Sub Function:
BiostatisticsJob Category:
Scientific/TechnologyAll Job Posting Locations:
High Wycombe Buckinghamshire United KingdomJob Description:
The Experienced Clinical Programmer is an experienced clinical trial programmer with in-depth knowledge in industry standard and complex data structures programming languages and/or reporting solutions with proven technical capabilities in leading clinical trial activities and/or teams in accordance with departmental processes and procedures.
The position is responsible for oversight or the development of one or more clinical data management trial activities of moderate to high complexity/criticality. Including data model specifications data stream integrations and transformation of source to internal data models and/or CDISC submission ready SDTM tabulation packages (aCRF cSDRG etc). Creates and executes edit check programs listings and report solutions to aid in monitoring of safety risk compliance and ensures quality data review.
Performs reporting solutions role creating study-specific reports translating clinical study team needs into specifications aggregating clinical data sources into custom data and report to monitor safety risk and compliance.
Accountable for one or more clinical programming trial activities of moderate to high complexity scope and/or criticality.
Performs comprehensive review of and provides input into project requirements and documentation. Identifies gaps proposes solutions and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables.
Ensures latest standards are being utilized current technologies are deployed.
Create and/or review specifications for mapping internal data review model for fit for purpose reporting and/or as well as submission ready CDISC SDTM. Design mapping algorithms for nonstandard conversions.
Responsible for creation or review of internal data model for fit for purpose reporting consumption and/or submission ready CDISC SDTM packages for health authority submissions and keeping abreast in changing regulatory requirements. Program or oversight of quality review checks study specific reports for use by team members and consumers of data.
May perform role that programmatically aggregates clinical data sources into custom data model for fit for purpose consumption study specific report solutions performing appropriate quality control and verification in support of assigned reporting activities.
Support and/or lead in developing and implementing process system and tool improvement initiatives within compliance with departmental processes and procedures.
Required Skills:
Preferred Skills:
Advanced Analytics Analytical Reasoning Biological Sciences Biostatistics Clinical Trials Data Modeling Data Privacy Standards Data Quality Data Savvy Detail-Oriented Good Clinical Practice (GCP) Report Writing Research Ethics Researching Statistical Analysis Systems (SAS) Programming Statistics Technologically SavvyRequired Experience:
Senior IC
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