Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Cr...
Job Description: We are seeking a highly experienced and motivated Manager, Regulatory Affairs, to join our growing Regulatory Affairs team. This role is critical to ensuring compliance with US regulatory requirements and supporting the de...
Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Cr...
Responsibilities: Provides SAS programming support to all clinical studies. Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables. Provide statistical programming support for regulatory su...
Responsibilities: Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision....
Responsibilities: Serve as the principal programming lead across multiple studies or a clinical program, ensuring timely, accurate, and regulatory-compliant deliverables. Lead or contribute to the development, validation, and documentati...
Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation to compliant to MDD and EU MDR. Defining worldwide regulatory requirements are necessary for regulatory approval of ...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Responsibilities: Support the Senior Director in developing and executing regional regulatory strategies for QOL. initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team, en...
Responsibilities: The statistical programming contractor independently manages completed projects that involve global tasks, or cross functional teams. The role may require providing inputs to design and analysis, and reporting the resul...