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Director, Statistical Programming (Remote) - Philadelphia Pennsylvania
Company: Jazz Pharmaceuticals Location: Philadelphia, Pennsylvania
Posted On: 05/03/2024
If you are a Jazz employee please apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description: The Director will be responsible for managing the product leaders and external FSP personnel, overseeing all ongoing clinical studies, and planning the operational aspects of all new clinical studies.The Director will support Integrated Data Analytics and Statistical Programming in statistical analysis and oversee statistical programming activities for all clinical studies. The Director will also maintain the programming process and ensure compliance with SOPs (Standard Operating Procedures) to produce quality and timely deliverables. In addition, the Director will use their strong people management skills to provide direct line management to regular and contract statistical programmers. -Essential Functions - Oversee Clinical Analysis Reporting Leads for delivery and execution based on planned timeline and strategic goals.
- Critically review programming strategy and timelines and impact on the clinical trials.
- Partner with Clinical Analysis Reporting Leads, respect their responsibilities, and constantly seek diverse perspectives. Encourage them to take educated risks and find new ways to solve problems.
- Collaborate with Biostatistics [clinical and medical affairs], data science, regulatory, clinical development, medical writing, and other vital functions and represent Statistical programming as the strategic partner to deliver the following but not limited to:
- A partner who is the advisor for the functional teams and represents the Statistical Programming
- Deliver the cross-functional process improvement projects as the single point of contact and or ensure within the Process improvement framework that they are completed
- Ensure adoption of the new technologies, the process developed with the Statistical Programming are adopted by the teams in the other departments
- Be the point of escalation and or contact remove any obstacles and or barriers for the Clinical Analysis Reporting Leads
- Work collaboratively with multiple product leads and manage strategic priorities and resources. - Make recommendations based on the workload for hiring FTE and FSP to the leadership team. -
- Work closely with management and finance partners to manage and maintain the statistical programming budget for FSP.
- Perform programming and QC for statistical programming deliverables as needed.
- Develop statistical programming performance requirements and measurements according to the Jazz standards. Perform ongoing assessment/measurement of team performance against set standards.
- Perform semi-annual and annual performance reviews and development plans for reports.
- Maintain a positive, results-orientated work environment, modeling teamwork and communicating to the team in an open, balanced, and objective manner.
- Qualifications:
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