Director, Statistical Programming

CSL

3d

About The Position

Provides either strategic leadership to, and management clinical programming within or across a designated Therapeutic Area (TA) or acts as an expert that supports the delivery of the portfolio. Fully accountable for all deliverables to support the TAs. Can be a member of Data Management, eClinical Operations, R&D Business Support, Clinical Programming as well as Performance Management.

Requirements

• Bachelor degree, or equivalent, in Science related discipline; post graduate qualifications in scientific or business related field preferable.
• 10+ years' experience working in clinical data management, statistical programming or clinical systems within the CRO/pharmaceutical environment.
• Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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.

Benefits

• For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
• At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
• To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
• CSL is an Equal Opportunity Employer.
• If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
• CSL is an Equal Opportunity Employer.
• If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.
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What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees