Therapeutics Inc.

Clinical Research

• Lead and manage the statistical aspects of assigned project portfolios
• Oversee and develop statistical and programming techniques to ensure quality and timely delivery of results
• Contribute to statistical sections of study protocols
• Perform sample size calculations
• Develop randomization specifications, plans, and schedules
• Review statistical input into case report forms, annotated case report forms, and database documentation
• Author Statistical Analysis Plans for studies and project deliverables
• Research, develop, and apply statistical methodologies and processes
• Develop, review, and provide input into SDTM and ADaM dataset specifications
• Create table and listing shells according to SAPs
• Generate database listings for database QA audits
• Assist data management and trial management teams with database lock preparation
• Write or supervise SAS programming and QC for SDTM and ADaM datasets, tables, figures, and listings for clinical study reports
• Perform statistical analyses and interpret results
• Collaborate with medical writers on integrated clinical study reports
• Contribute to regulatory submissions, including ISS and ISE development and responses to regulatory questions
• Interact with Clinical Development Team members to support client satisfaction
• Participate in Clinical Development Team and client meetings
• Help build departmental infrastructure, programming standards, SAS macro and program libraries, and workload forecasts

Explore Senior Biostatistician at Therapeutics Inc.. Review requirements and application details.