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Overview
The primary responsibilities of this position are to assist with study level statistical related activities, particularly to write statistical analysis plans, prepare mock tables/figures/listings, and generate statistical analyses for clinical studies.
Responsibilities
• Review study protocols and assist with protocol preparation
• Assist with sample size and power calculation
• Assist with randomization schedule generation
• Review case report forms to ensure appropriate data collection
• Review edit checks algorithm to ensure data quality for statistical analyses
• Participate in study team operations and timeline discussion
• Prepare statistical analysis plans
• Prepare mock tables, figures, and listings
• Review programming specifications and work with statistical analysts/programmers to prepare CDISC compliant SDTM and ADaM datasets
• Conduct inferential statistical analyses and check model adequacy of statistical analyses
• Perform statistical validation/quality control on analyses generated by statistical analysts/programmers
• Conduct ad-hoc analyses and data mining
• Write statistical reports for results interpretation if needed
• Participate in clinical results interpretation meetings
• Work with medical writers to assist with clinical study reports preparation
• Work with project managers to ensure timely and high quality delivery of analysis packages
Qualifications
Master’s degree in statistics or biostatistics
Experience
Master’s degree with 0-2 years of relevant experience in statistical analyses
Skills
• Good understanding in statistical concepts and methods
• Working knowledge of SAS and/or R
• Good interpersonal and communication skills
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Job Locations US-CA-San Diego
Job ID 2024-13139