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CSL · 1 hour ago

Director, Statistical Programming

King of Prussia, PA

Full-time

Onsite

Director/Executive

10+ years exp

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. The Director of Statistical Programming will provide strategic leadership and management of clinical programming within designated Therapeutic Areas, ensuring high-quality data management and operational data strategies to support clinical programs.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

Working with key stakeholders, drives the overall clinical data strategy and operational data management across all clinical programs. Supports the entire data flow of clinical programs and studies to enable delivery of high-quality, consistent and integrated datasets for regulatory submissions. Where required, support the broader R&D data strategy through systems and processes

Working with key stakeholders, drive Innovative data solutions and technologies (e.g. digital transformation) to improve patient and investigator sites experience

Manage the entire eClinical Technology suite of systems for the Therapeutic areas. Translate business needs into the eClinical Roadmap. Implement, maintain and support eClinical solutions. Configure and integrate eClinical solutions on project and study level

Apply Business Intelligence reporting to enable data driven decisions

Assess industry landscape and develop strategies for future growth, scalable solutions and integration of new technologies and data sources (e.g. mobile data collection)

Ensure all activities that support the TA model are successfully planned, implemented and completed in accordance with the Company strategy, appropriate international regulatory standards, and within the agreed timeframe and budget

Responsible for overall forecasts and management of budgets and resource allocation in collaboration with the Department Heads and clinical teams

Develop or support the development of the processes, systems and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards

Drive a culture of continuous improvement, always looking for way to reduce cost and timelines, while maintaining the highest level of quality

Seen as a technical expert in their discipline, who is sought out for their experience

Qualification

Clinical data managementStatistical programmingEClinical technologyBusiness Intelligence reportingRegulatory complianceContinuous improvementStakeholder managementLeadership