Associate Director, Biostatistics at JAZZ PHARMACEUTICALS PLC in Philadelphia, PA

Overview:

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.

Responsibilities:

The Associate Director, Biostatistics will function as the statistical lead on a Jazz Pharmaceuticals clinical development project or as the statistical lead for individual clinical trials. This position will work collaboratively with clinicians from Research and Development as well as Global Medical Affairs, data managers, biostatisticians, and statistical programmers to plan, conduct, and analyze clinical studies of all phases. 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 Global Molecule Team discussions.

Essential Functions

• Lead the biostatistics function and personnel to develop and execute statistical strategy, design, and analyses for clinical trials
• Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results
• Provide guidelines and standards to CROs and instructions for derivations and analyses to Jazz Statistical Programming to ensure quality of deliverables
• Work with department head, peers, and cross-functional colleagues to develop, implement, and maintain department standards and practices
• Help design data capture methods and select appropriate study endpoints for clinical programs
• Attend meetings with regulatory agencies to support clinical programs and respond to statistical questions from regulatory agencies
• Collaborate with researchers and thought leaders to plan clinical development programs 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
• Develop statistical programs as necessary to perform analysis, prepare data displays, and verify the correctness of data and analyses
• Recruit, develop, and supervise internal and external statistical resources to achieve department functional goals

Minimum Requirements

• PhD or Master's Degree in Statistics, Mathematics, or related fields
• PhD with >4 years of experience OR master’s with >6 years of experience in pharmaceutical or biotechnology industry is required
• Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials
• Good knowledge of drug development regulations pertinent to statistical analysis
• Experience in contributing to NDAs/BLAs submission and defense
• Proficient SAS programming skills, solid understanding of CDISC models and standards
• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills