Senior Director, Biostatistics

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: September 15, 2021

Job Description:

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 Senior Director, Biostatistics will act as the statistical expert and overall statistical leader providing oversight and strategic input for the therapeutic area.  This position will have direct reports up to Director level, participate in critical regulatory interactions, provide statistical leadership and expertise, be accountable for the quality and timeliness of all biostatistics analyses, and ensure consistency of strategy from statistical perspectives across the therapeutic area.  Leads development of departmental processes and procedures, including establishing standards and operating procedures.    Works collaboratively across Research and Development functional areas to coordinate Biometrics and Biostatistical initiatives.  Oversees professional development of therapeutic area biostatisticians.

Essential Functions

• Lead the biostatistics function and personnel to develop and execute statistical strategy, design, and analyses for clinical trials within the therapeutic area.  
• Manage biostatisticians within the therapeutic area.
• Lead cross-functional teams or represent the VP, Biometrics on teams to develop, implement, and maintain department and Research and Development standards and practices.
• Provide statistical and drug development expertise in collaborations with researchers and thought leaders to plan clinical development programs.
• Ensures the timely delivery of quality analysis results by internal and CRO resource.

• Perform senior management review of regulatory briefing documents, responses, and submissions; attend meetings with regulatory agencies as necessary.

• Be able to conduct independent research and resolve statistical methodological issues.
• Recruit, develop, and supervise internal and external statistical resources to achieve department and company goals.
• Leads outsourcing statistical activities within a therapeutic area.

Required Knowledge, Skills, and Abilities

• Expert knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, 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 comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis.
• Expert knowledge of drug development regulations pertinent to statistical analysis.
• Experience in providing statistical leadership to NDA or BLA submissions, supporting review, and experience in regulatory interactions is required.
• Experience managing CROs and overseeing contracts and invoices.
• Bayesian and adaptive design experience.
• Proficient in SAS, solid understanding of CDISC models and standards.
• Excellent writing and communication skills, demonstrated leadership abilities, and excellent interpersonal skills.
• Strong attention to detail with a view to bring studies to a quality conclusion.
• Able to work in a fast-paced, flexible, team-oriented environment.
• Flexible, positive, creative thinker, good communicator.
• Work independently; well-developed time management skills are imperative.

 Minimum Requirements

• PhD or MS degree in statistics, mathematics, or a related discipline with a statistical focus. 
• A minimum of 10 years of experience; supervisory experience is preferred.
• Knowledge of the oncology or hematology therapeutic area is required.
• Expert knowledge of drug development strategies and regulations, especially those pertinent to statistical analysis.
• Bayesian and adaptive design experience.
• Experience in contributing to NDA or BLA submissions and defense is required.
• Proficient SAS programming skills, solid understanding of CDISC models and standards.
• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.

Description of Physical Demands

• Occasional mobility within office environment.
• Routinely sitting for extended periods.
• Constantly operating a computer, printer, telephone, and other similar office machinery.

Description of Work Environment

• Works indoors in normal office environment with little exposure to excessive noise, dust, fumes, and temperature changes.
• Computer use at a workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of normal work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.

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.

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