Associate Director, Clinical Data Programmer at Amylyx · LumiJobs

Responsibilities

The Clinical Data Management team at Amylyx Pharmaceuticals is seeking an Associate Director, Clinical Data Programmer. This individual will work collaboratively cross-functionally to provide hands-on data management support, programming support and technical leadership to develop, maintain, validate the clinical database, and run computer programs that access, visualize, and report clinical trial data, in accordance with various clinical plans, ICH guidelines, and applicable regulatory requirements. As an Associate Director of Clinical Data Programming, you will be required to program in the appropriate languages to create both textual and graphic displays that facilitate data cleaning and review.
Serve as the inter-department subject matter expert for EDC platforms (Medidata RAVE) including management of the environment as well as the standards library to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making
Contribute to development process and ensure compliance from a CDM / EDC and data programming perspective including SOPs, standardization of operational and technical methodologies
Provide technical and functional oversight of the day-to-day use of CDM systems and related processes, as needed, including EDC build standards, clinical data collection, processing, system integrations, and quality control procedures, timelines, and documentation
Participate in the evaluation and selection of future CDM systems infrastructure and solutions including clinical programming and data visualization tools
Leads the study-specific design, development, and validation of study clinical data capture systems, ensuring data integrity, CDISC compliance and CRO oversight.
Supports leading data management activities (i.e. DMP creation, CRF creation, edit checks creation, database lock), assisting with database setup, conduct and closeout phases.
Performs UAT of systems and ensures appropriate plans and documentation are in place.
Leads the development of SAS macros, data listings, summary tables and visualizations for supporting periodic and ad hoc data review.
Manages external vendor compliance and quality checks.
Supports Clinical Operations, Biostatistics and Data Management by providing data insight and solving technical data challenges.
Ensures databases adherences to SOPs, 21CRF Part 11, ICH-GCP and CDISC Standards (CDASH/SDTM)

Associate Director, Clinical Data Programmer

Responsibilities

Qualification

Required

Benefits

Company

Amylyx

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