Jazz Pharmaceuticals

If you are a current Jazz employee please apply via the Internal Career site

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 www.jazzpharmaceuticals.com for more information.

Job Description

The Associate Director, Biostatistics and Data Analytics will function as the statistical lead for statistical monitoring on assigned Jazz Pharmaceuticals drug development clinical trials. The statistical monitoring lead will be responsible for overseeing the statistical aspects of clinical trials, ensuring that the trial design, execution, and reporting adhere to regulatory standards and best practices. This position involves collaboration with clinical teams including clinicians, data managers, other biostatisticians, and statistical programmers, providing statistical support, and conducting statistical monitoring throughout the lifecycle of a clinical trial. The role will be essential in identifying, analyzing, and addressing any statistical issues that arise during the trial, ultimately ensuring the accuracy and integrity of trial data. This position may have direct reports.

Essential Functions

• Participate in or lead department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• Perform statistical monitoring of clinical trial data to ensure data quality and integrity.
• Review and assess interim and final trial data to identify trends, anomalies, and potential issues.
• Collaborate with clinical teams to resolve statistical issues and ensure that clinical trials are executed according to the study protocol.
• 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
• Recruit, develop and supervise internal statisticians.

Required Knowledge, Skills, and Abilities

• Knowledge of clinical trial design and analysis, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, principles of sample size calculations and phase I-IV clinical trial data analysis.
• Good knowledge and experience working in Oncology therapeutic area
• Experience in using SAS or R; knowledge of other statistical applications and programming languages a plus.
• Thorough knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.
• Able to work in a fast-paced, flexible, team-oriented environment.
• Possess excellent interpersonal and communication skills (written and verbal).
• Strong attention to detail.
• Flexible, positive, creative thinker, good communicator.
• Work without close supervision. Time management skills are important.

Required/Preferred Education and Licenses

• PhD with > 4 years of experience or MS with > 6 years of experience
• Degree in statistics, mathematics, or a related discipline with a statistical focus.
• Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials.
• Expert knowledge of drug development regulations pertinent to statistical analysis.
• Experience in contributing to NDA or BLA submissions and defense.
• Proficient SAS programming skills, comprehensive understanding of CDISC models and standards.
• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills

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 full and complete base pay range is:

$164,000.00 - $246,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

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.html