Senior Director, Biostatistics

Brief Description:

The Medical Affairs and Value Statistics (MAVS) team at Jazz is a pivotal part of the Evidence and Value Generation function. This team partners with Medical Affairs and HEOR to design best-in-class studies and analyses to further characterize safety, efficacy, and effectiveness of our products to the medical, payer and patient communities.

The Senior Director, Medical Affairs and Value Statistics will lead the MAVS team to help shape the evidence generation and communication strategy of our products through effective and efficient designs and analysis plans, implementing cutting-edge statistical methods such as observational studies methods, Bayesian, meta-analyses, various bias reduction methodologies, ML/AI, data visualization/exploration and pragmatic study design.

Specifically, MAVS leads secondary/tertiary publications from the clinical trials supporting global registrations, phase IV study designs and post-marketing requirements, supporting the Integrated Evidence Generation Plan (IEGP) and relevant HTA submissions. This individual will also have responsibility for Real World Evidence statistical methodology, ensuring that we have valid statistical methods in place for each study and proposing new/innovative methods where needed. In addition to developing and implementing the team's statistical strategies, the Senior Director will lead statistical activities for one of Jazz' marketed projects.

This individual should be genuinely excited about statistics and the impact we can have on patients through effective communication of data. They should understand the role of statistics and unique methodologies applicable to both the Global Medical Affairs community and the HEOR community. They will represent Jazz as an internal and external stakeholder in various forums and conferences and may interact with regulatory agencies on matters related to Jazz's products. The Senior Director will be asked to think outside the box to innovate, collaborate, and enhance the medical affairs and the value statistics organizations.

Finally, they must commit to continuing to make Jazz a great place to work by delivering on our purpose to "Innovate to transform the lives of patients and their families" and vision to "Foster a great place to work dedicated to championing patients globally by discovering, developing and commercializing life-changing medicines".

Essential Functions/Responsibilities

• Lead MAVS team in development and execution of phase IV study designs in collaboration with Global Medical and Scientific Affairs
• Lead Jazz' statistical strategy for secondary/tertiary publications via post-hoc analyses of existing clinical trial data
• Collaborate with HEOR to anticipate evidence needs for payers and provide statistical support for HTA submissions
• Support and advise on statistical methodology for real-world evidence studies
• Manage a team of biostatisticians
• Work with the Evidence and Value Generation leadership team and MAVS team members to develop, implement, and maintain department standards and practices
• Provide statistical and drug development expertise in collaboration with researchers and thought leaders, in the planning of the IEGP, and the studies that support them
• Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors
• Attend clinical meetings to present data supporting our products, learn other relevant analytical methods that could support the IEGP and interact with relevant leaders in the medical community
• Present study results and database analyses to internal and external audiences
• Be able to conduct independent research and resolve statistical methodological issues
• Recruit, develop, and supervise internal and external statistical resources to achieve department functional and company goals
• Maintain awareness and set vision for the use of cutting-edge statistical methods such as observational studies methods, Bayesian statistics, meta-analyses, various bias reduction methodologies, ML/AI, data visualization/exploration and pragmatic study design

Required Knowledge, Skills, and Abilities

• Experience in a similar role as well as supervisory experience
• Good knowledge of drug development regulations and payer expectations pertinent to statistical analysis
• Experience in providing statistical leadership to HTA submissions and IEGP planning
• Proficient in SAS, solid understanding of CDISC models and standards
• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills
• Commitment to continuing to make Jazz a great place to work by delivering on our purpose to "Innovate to transform the lives of patients and their families" and vision to "Foster a great place to work dedicated to championing patients globally by discovering, developing and commercializing life-changing medicines".

Required/Preferred Education and Licenses

• PhD in Statistics, Mathematics, or related fields

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