Associate Director, Oncology Statistics - Remote

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 Associate Director, Biostatistics will function as the statistical lead on a Jazz Pharmaceuticals drug development project or as the statistical lead for individual/related clinical trials 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 may manage work done by statistics and programming external vendors. Oversees professional development of any direct reports.

Essential Functions

• Participate in or lead department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• In conjunction with the project statistical lead, develop and execute statistical strategy, design, and analyses for clinical trials
• 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
• Manage CRO statistical activities to ensure timely delivery of quality analysis results.
• 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.

Required Knowledge, Skills, and Abilities

• Knowledge of phase I-IV clinical trial design and analysis, including experience with complex statistical methods and models and sample size calculations.
• 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.

Minimum Requirements

• 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.

• Knowledge of the oncology or hematology therapeutic area is preferred.
• Bayesian and adaptive design experience is preferred.
• 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 anticipated base pay range is $160,000-$210,000. 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