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Associate Director, Biostatistics

Company: Jazz Pharma
Location: Palo Alto
Posted on: March 28, 2020

Job Description:

Job DescriptionOverview: 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 be functioning as a statistical lead on Jazz Pharmaceuticals clinical development projects. This position will work collaboratively with clinicians, data managers, biostatisticians, and statistical programmers in the planning, conduct, and analysis of clinical studies in all phases. 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 to ensure quality of deliverables * Work with department head, peer management, and employees 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 and support/defend clinical programs, respond to statistical questions from regulatory agencies * Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data * 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, verify data accuracy and validity * 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 * A minimum of 6-8 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 * Extensive 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 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.

Keywords: Jazz Pharma, Palo Alto , Associate Director, Biostatistics, Executive , Palo Alto, California

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