Job Description:
• Lead complex studies such as NDA submissions or multi-protocol programs, coordinating activities across locations.
• Perform project management activities including resource planning, timelines, and milestone management.
• Serve as DMC Support Statistician, developing Charters and attending DMC Meetings.
• Lead development of Statistical Analysis Plans, perform senior reviews of plans developed by others.
• Conduct statistical review of TFLs for complex studies prior to delivery.
• Review study-specific specifications.
• Provide mentoring and training to less experienced staff.
• Present knowledge at seminars and external meetings.
• Attend bid defense meetings for complex studies.
• Represent the department during audits.
Requirements:
• Bachelor’s degree.
• 8+ years of experience or an equivalent combination of education or experience.
• Ability to program in one or more statistical software packages (SAS®).
• Proficiency in SAS including use of various statistical procedures (non-parametric analysis, linear and non-linear models, categorical data, survival analysis).
• Proven ability to effectively communicate statistical concepts.
• Good knowledge of the overall clinical trial process.
• Competence in preparation of Statistical Analysis Plans, analysis, reporting across a variety of trials.
• Preferred: Master’s degree in Biostatistics or related field.
Benefits:
• Competitive Compensation: We offer a competitive salary package, comprehensive benefits, and a rewarding bonus structure.
• Life-Style: Flexibility to work remotely from anywhere, promoting a healthy work-life balance.