Associate Director, Biostatistics

Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit  for more information.

The Associate Director, Biostatistics will function as the statistical lead on a Jazz Pharmaceuticals drug development project or as the statistical lead for individual clinical trials, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings. This position may have direct reports. This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation.

The Associate Director will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. The incumbent will work collaboratively with clinicians, data managers, other biostatisticians, and statistical programmers to plan, conduct, and analyze clinical studies, including integrated reporting. Lead (if the statistical lead on a clinical development project) or support (if the statistical lead for individual clinical trials) statistical input and strategy in governance team discussions.

Contributes to or leads the development of departmental processes and procedures, including establishing standards and operating procedures. The Associate Director will manage work done by statistics and programming external vendors. Oversees professional development of any direct reports.

• Participate in or lead department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• Lead, develop and execute statistical strategy, design, and analyses for clinical trials within a project(s)
• Develop or review statistical analysis plans and interpret data.
• Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming
• Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices.
• Attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies.
• Collaborate with researchers and thought leaders to plan clinical development projects and, if appropriate, publications of study results.
• Present study results to internal and external audiences
• Be able to conduct independent research and resolve statistical methodological issues
• Recruit, develop and supervise internal and external statisticians.

• Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for…