Therapeutics Inc.

Clinical Research

• Leadership and Project Management of statistical aspects of assigned project portfolio
• Oversight and development of statistical and programming techniques to ensure quality and on time delivery of generated results
• Contribute to the writing of statistical sections of study protocols
• Perform sample size calculation, develop randomization specifications
• Review and provide statistical input into the development of case report forms design
• Author Statistical Analysis Plans (SAPs)
• Research, development and application of statistical methodologies and processes
• Develop and/or review SDTM and ADaM dataset specifications
• Create table and listing shells per the SAP
• Generate database listings for QA audits
• Assist data management and trial management team in preparing for database lock
• Write and/or supervise SAS programming and QC to create SDTM and ADaM data sets
• Perform statistical analyses of data and interpret results
• Collaborate with medical writer in the production of integrated clinical study reports
• Contribute to the regulatory submissions including development of Integrated Summaries of Safety (ISS) and Efficacy (ISE)
• Interact with members of the Clinical Development Team
• Participate in Clinical Development Team meetings and client meetings
• Participate in departmental infrastructure building and maintain programming standards.

Senior Biostatistician