Biostatistician II – Early Development Studies

• Function independently as a lead statistician
• Deliver project statistician tasks and responsibilities, including statistical analyses
• Develop table, listing and figure specifications
• Review formatted datasets and statistical results, tables, listings and figures
• Ensure compliance with departmental SOPs and procedures for statistical analyses and programming
• Lead project teams, conduct meetings, maintain timelines, assess and provide resources, and prepare budgets
• Ensure SOP compliance and maintain appropriate project documentation
• Interact with sponsors on all project aspects
• Coordinate with programmers and data management personnel on database maintenance, updating and documentation
• Provide guidance on database structures for analysis
• Provide sample size calculations
• Review protocols for completeness, clinical design appropriateness, and sound statistical analysis
• Provide randomization schemes and documentation
• Develop statistical analysis plans, including table, listing and figure specifications
• Perform SAS programming, including preparation of analysis-specific datasets and implementation of statistical models
• Review reports, documents and manuscripts; contribute to statistical methods sections and verify completeness and consistency
• Monitor project budgets against work scope and communicate potential scope changes to management

• Master's degree in statistics, biostatistics, mathematics or related field
• 2+ years of experience working in Biostatistics
• Previous CRO experience is desirable
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered sufficient
• Solid SAS programming experience, proficient in BASE, STAT, MACRO and GRAPH
• Working knowledge of statistical modeling in SAS
• Knowledge of R would be an advantage
• Solid understanding of statistical principles and good statistical skills
• Ability to create table, listing and figure specifications and support review of study deliverables
• Good project management skills demonstrated through management of multiple studies
• Solid written and verbal communication skills, including proficiency in English
• Good organizational skills and ability to adapt to changing priorities
• Ability to promote teamwork in a multi-disciplinary and global team setting
• Positive attitude and ability to work well with others
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards

• Fully remote/work-from-home position
• Flexibility in working hours to accommodate collaboration and meetings within a global organization
• Additional flexibility during onboarding and training to ensure overlap with international team members