Jazz Pharmaceuticals, Inc. – $60,861.00/Year

Must have at least 1 year of prior work experience in a pharmaceutical or biotechnology industry in each of the following 1. Serving as a lead statistician and collaborating with other divisions including data management, clinical operation, programming, medical writing, regulatory teams, and leading execution of statistical related activities; 2. Providing and reviewing sample size calculations and protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributing to writing appropriate protocol sections, including study design elements. Providing and reviewing randomization related documentation; 3. Developing statistical analysis plan and TLF shells and facilitating the implementation of statistical analyses. Defining appropriate methods and procedures for statistical analysis. Performing and reviewing statistical analysis for key efficacy endpoints; 4. Preparing statistical reports and documents and providing statistical inputs and data interpretations to the statistical sections for clinical study reports, integrated summaries of safety, integrated summaries of efficacy, questions from regulatory agencies, scientific presentations, and manuscripts; 5. Reviewing specifications of analysis database and participate in their validation to assure completeness for use in all programming. Collaborating with programming and data management personnel as to database maintenance, updating and documentation; 6. Using SAS or R programming language to perform various statistical analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming; 7. Providing input on department process including improvement, training, and department policies or SOP development; and 8. Ensuring compliance with the activities outlines in the departments SOPs and contributing changes as needed. Following departmental procedures for statistical analyses and programming work and provide guidance and standards to vendors to ensure timeliness and quality of deliverables.br br Position permits telecommuting.