Senior Director, Medical Affairs And Value Statistics (Remote)

If you are a Jazz employee please apply via the Internal Career site
Jazz 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 Medical Affairs and Value Statistics group at Jazz is a pivotal part of the RWE, Epidemiology and Medical Affairs Statistics (REM) organization within Data Science. This team is responsible for partnering 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 this organization to provide statistical partnership 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 Bayesian, meta-analyses, various matching methodologies, ML/AI, data visualization/exploration and pragmatic study design.
Specifically, their team will lead secondary/tertiary publications from the clinical trials supporting global registrations, phase IV study designs and post-marketing requirements, supporting the Integrated Evidence Generation Plan 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 it matters. 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 Value Statistics organization.
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

• Lead the Medical Affairs and Value biostatistics function and personnel to develop and execute statistical strategy for secondary/tertiary publications from our clinical trials supporting global registrations, phase IV study designs and post-marketing requirements supporting the IEGP as well as having responsibility statistical support of HTA submissions and real-world evidence statistical methodology
• Manage a team of biostatisticians within the organization.
• Work with RWE, Epidemiology and Medical Affairs Statistics (REM) head, peers, and employees to develop, implement, and maintain department standards and practices
• Provide statistical and drug development expertise in collaborations with researchers and thought leaders, in the planning of integrated evidence generation plans 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.
• Anticipate the evidence needs for payers and provide statistical support for our company HTA submissions
• 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 Bayesian statistics, meta-analyses, various matching methodologies, ML/AI, data visualization/exploration and pragmatic study design.

Required Knowledge, Skills, and Abilities

• A minimum of 10 years of experience with at least 3 years of supervisory experience is preferred
• 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

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US-BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $224,000-$294,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits