The role of the Senior Statistical Analyst is to perform statistical programming activities for all assigned Phase I-IV clinical studies sponsored by AbbVie and its partners. This position performs statistical programming for clinical studies, integrated summaries, and in support of responses to requests from regulatory authorities. This position can serve as a study lead for an assigned study.
Responsibilities:
- Lead statistical programming activities and provide programming/documentation support for multiple studies
- Review statistical analysis plans for assigned studies and integrated summaries; provide comments to the study biostatistician
- Create ADaM data set specifications and data sets
- Ensure study analysis is consistent with standard templates and specifications
- Contribute to submission support and urgent regulatory agency requests
- Follow timelines for assigned study tasks
- Coordinate own task assignments
- Participate in Statistical Programming process improvement initiative
- Manage timelines and ensure communication with CROs/FSPs and internal teams (statistics, data management, medical writing, regulatory publishing, clinical operations)
- Oversee programming tasks for a single study
- Conduct high-level review of CRO/FSP deliverables for quality and accuracy
Qualifications:
Minimum
- Degree in Statistics, Mathematics, or Engineering
- 6+ years relevant experience (with MS) OR 8+ years (with BS)
- SAS programming experience related to drug development
- Experience with regulatory filings
- Experience adhering to CDISC standards and creating/reviewing ADaM specifications
Preferred
- Knowledge of R or Ai is a plus
Other required skills
- In-depth SAS programming knowledge for drug development
- Fundamental understanding of CDISC standards and drug development process
- Clear oral and written communication
- Ability to estimate effort for study programming activities
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) (to eligible employees)
- Eligible for short-term incentive programs