• Working knowledge of SAS, familiar with SAS/GRAPH, and SAS/MACRO
• Production of statistical reports and the programming of tables, listings and figures
• Detailed understanding of industry standards for database design (CDISC: SDTM, ADaM)
• Excellent analytical, problem solving, communication and organization skills with the ability to work simultaneously in multiple tasks and teams
• Ability to work in a collaborative environment, drive to learn and improve skills
• Ability to communicate statistical interpretation to non-scientists
• Produce tables, figures and data listings using efficient programming techniques
• Perform statistical analyses under close supervision
• Assist in the production of statistical reports and statistical sections of integrated clinical reports
• Check own work in an ongoing manner to ensure first-time quality
• Plan, communicate and implement the surveillance of the statistical programming activities performed by a CRO.
• Provide statistical programming support for Data Monitoring Committee charters and associated statistical programming deliverables.
• Coordinate statistical programming activities ensuring timelines are met and best practices implemented.
• Travel to, attend and actively contribute to required sponsor meetings as appropriate (e.g.) presenting and discussing study results accompanying the Senior Biostatistics)
• Communicate process improvement ideas within the department
• Additional responsibilities as defined by supervisor/manager
Minimum Education & Experience Requirements:
• MS in biostatistics, statistics, mathematics or related field with minimum 5 years experience in biotech/pharma or CRO
• Proficient in SAS programming
• Extensive knowledge of relevant regulatory guidelines applicable to clinical development
• Experience with NDA Preparation
• Solid working knowledge of the relevant statistical and therapeutic areas (Oncology required)
• Competent in written and oral English
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