Senior Statistical Analyst

Summary

Join AbbVie as a Senior Statistical Analyst and play a key role in the research and development of new pharmaceutical products. This position involves analyzing and reporting clinical trial data, leading statistical programming for clinical studies, and collaborating with various stakeholders. You will create documentation for regulatory filings, develop SAS macros, and mentor junior team members. The role offers remote or hybrid work options within the US. AbbVie provides a comprehensive benefits package including paid time off, health insurance, and a 401(k).

Requirements

• MS in Statistics, Computer Science or a related field with 5+ years of relevant experience
• OR BS in Statistics, Computer Science or a related field with 7+ years of relevant experience
• Indepth understanding of SAS programming concepts and techniques related to drug development
• Fundamental understanding of CDISC Standards
• Fundamental understanding of the drug development process, including experience with regulatory filings
• Ability to communicate clearly both oral and written
• Ability to accurately estimate effort required for study related programming activities

Responsibilities

• Lead the statistical programming activities for projects with lower complexity
• Lead the statistical programming activities for studies
• Create documentation for regulatory filings including reviewers guides and data definition documents
• Lead the development of standard SAS Macros
• Provide oversight and mentoring of assigned Statistical Programmers and Statistical Analysts
• Develop SAS programs for the creation of ADaM data sets following CDISC standards
• Develop SAS programs for the creation of Tables, Listings and Figures
• Validation of ADaM data sets, Tables, Listings and Figures
• Create specifications for the structure of ADaM data sets for individual studies and integrated data
• Participate in the development of standard operating procedures

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs