If you are presently part of the Jazz team, please apply through the Internal Career site. Jazz Pharmaceuticals is a leading global biopharmaceutical company, committed to innovating and enhancing the lives of patients and their families. Our mission revolves around developing transformative medications for individuals facing serious health challenges, often when there are limited or no available treatments. Our diverse portfolio includes prominent therapies for sleep disorders, epilepsy, and an expanding range of cancer treatments. Driven by a patient-centric and scientifically informed approach, we are dedicated to groundbreaking research and development across our extensive pipeline of innovative products in oncology and neuroscience. Our headquarters are situated in Dublin, Ireland, with research and development labs, manufacturing sites, and a talented workforce spread across various countries, all focused on serving patients globally. For more information, please visit our website.

We are looking for an Associate Director of Biostatistics and Data Analytics to take on a pivotal role as the statistical lead in monitoring Jazz Pharmaceuticals’ clinical trials. In this capacity, you will oversee the statistical elements of clinical trials, ensuring that study design, execution, and reporting adhere to the highest regulatory standards and best practices. This role requires collaboration with clinical teams, including clinicians, data managers, and fellow biostatisticians, providing essential statistical guidance and conducting ongoing statistical monitoring throughout the duration of clinical trials. You will play a crucial part in detecting, analyzing, and resolving statistical issues that may arise during the study, thereby ensuring the reliability and accuracy of trial data. This position may include direct supervision of other staff.

Key Responsibilities:

• Lead and participate in departmental and cross-functional meetings to enhance clinical study designs, endpoints, and analytical strategies in protocols.
• Conduct statistical monitoring of clinical trial data to guarantee data quality and integrity.
• Review interim and final trial data to pinpoint trends, discrepancies, and potential challenges.
• Work closely with clinical teams to address and resolve statistical challenges, ensuring adherence to the study protocol.
• Develop statistical programs as needed for simulating clinical trial design characteristics, performing analyses, preparing data visualizations, and validating the accuracy and integrity of statistical programming outputs.
• Contribute to or lead Biometrics teams in the formulation, implementation, and maintenance of departmental standards and practices.
• Attend meetings with regulatory authorities; adeptly respond to statistical inquiries from these agencies.
• Collaborate with research partners and thought leaders to strategize clinical development projects and potential study result publications.
• Present findings from studies to both internal and external stakeholders.
• Recruit, mentor, and supervise internal statisticians.

Essential Qualifications and Skills:

• Comprehensive understanding of clinical trial design and analysis, including statistical principles and methodologies, hypothesis testing, and sample size estimation for phase I-IV clinical trials.
• Strong experience in the oncology therapeutic area.
• Proficient in SAS or R; familiarity with additional statistical tools or programming languages is advantageous.
• In-depth understanding of applicable regulatory requirements and guidelines, including ICH Guidelines and statistical regulations relevant to drug development, as well as knowledge of CDISC SDTM and ADaM standards.
• Ability to thrive in a dynamic, team-oriented environment.
• Excellent communication and interpersonal skills, both written and verbal.
• Detail-oriented, flexible, and a creative thinker with effective time management abilities.

Education and Experience:

• PhD with over 4 years of relevant experience or MS with more than 6 years of experience in statistics, mathematics, or a related field with a statistical focus.
• Extensive knowledge of clinical trial design and statistical applications.
• Expertise in drug development regulations related to statistical analysis, including contributions to NDA or BLA submissions.
• Strong proficiency in SAS programming and a solid understanding of CDISC standards.
• Exceptional writing skills and demonstrated leadership capabilities.

Jazz Pharmaceuticals is proud to be an equal opportunity/affirmative action employer. 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 candidates based in the U.S.: Jazz Pharmaceuticals, Inc. is dedicated to fair and equitable compensation practices. We provide competitive total compensation packages. The base pay range for this role is $164,000 – $246,000. Individual compensation within this range will depend on various factors, including qualifications, skills, relevant experience, and overall job knowledge. Our aim is to ensure fair remuneration aligned with the candidate’s expertise and contributions while maintaining internal equity. This pay range will be reviewed regularly.

In addition to base pay, the successful candidate may have the opportunity for an annual discretionary cash bonus or incentive compensation according to the Company’s Global Cash Bonus Plan or Incentive Compensation Plan, as well as potential discretionary equity grants in line with Jazz’s Long Term Equity Incentive Plan. The successful candidate will also be eligible for a variety of benefits, including medical, dental, and vision insurance, a 401(k) retirement savings plan, and flexible paid vacation. For more information on our benefits offerings, please click here.