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. The medical affairs and value statistics organization at Jazz is a pivotal part of Biometrics. This team is responsible for partnering with Global 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 design strategies 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 the secondary/tertiary publications from the clinical trials supporting global registrations, phase IV study designs and post-marketing requirements supporting the IEGP as well as analyses that support relevant HTA submissions. This individual will also have responsibility for Real World Evidence statistical methodology, ensuring that we have the valid statistical methods in place for each study and proposing new/innovative methods where it matters. 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 FunctionsLead 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 methodologyManage a team of biostatisticians within the organization.Work with Biometrics head, peers, and employees to develop, implement, and maintain department standards and practicesProvide 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 submissionsPresent study results and database analyses to internal and external audiencesBe able to conduct independent research and resolve statistical methodological issuesRecruit, develop, and supervise internal and external statistical resources to achieve department functional and company goalsMaintain 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 AbilitiesA minimum of 10+ years of experience with at least 3 years of supervisory experience is preferredGood knowledge of drug development regulations and payer expectations pertinent to statistical analysisExperience in providing statistical leadership to HTA submissions and IEGP planningProficient in SAS, solid understanding of CDISC models and standardsExcellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skillsCommitment 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 LicensesPhD in Statistics, Mathematics, or related fieldsJazz 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.
Disability Solutions
Palo Alto California
United States
Healthcare - Allied Health
(No Timezone Provided)
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. The medical affairs and value statistics organization at Jazz is a pivotal part of Biometrics. This team is responsible for partnering with Global 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 design strategies 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 the secondary/tertiary publications from the clinical trials supporting global registrations, phase IV study designs and post-marketing requirements supporting the IEGP as well as analyses that support relevant HTA submissions. This individual will also have responsibility for Real World Evidence statistical methodology, ensuring that we have the valid statistical methods in place for each study and proposing new/innovative methods where it matters. 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 FunctionsLead 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 methodologyManage a team of biostatisticians within the organization.Work with Biometrics head, peers, and employees to develop, implement, and maintain department standards and practicesProvide 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 submissionsPresent study results and database analyses to internal and external audiencesBe able to conduct independent research and resolve statistical methodological issuesRecruit, develop, and supervise internal and external statistical resources to achieve department functional and company goalsMaintain 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 AbilitiesA minimum of 10+ years of experience with at least 3 years of supervisory experience is preferredGood knowledge of drug development regulations and payer expectations pertinent to statistical analysisExperience in providing statistical leadership to HTA submissions and IEGP planningProficient in SAS, solid understanding of CDISC models and standardsExcellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skillsCommitment 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 LicensesPhD in Statistics, Mathematics, or related fieldsJazz 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.