Senior Statistical Analyst - Programmer (Hybrid)

Senior Statistical Analyst perform statistical programming activities for assigned Phase I–IV clinical studies sponsored by AbbVie and partners, including clinical studies, integrated summaries, and support for responses to regulatory authorities. Can serve as 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 study biostatistician
- Create ADaM data set specifications and ADaM datasets
- Ensure study analysis is consistent with standard templates and specifications
- Contribute to submission support and support urgent regulatory agency requests
- Follow timelines for study tasks; coordinate own task assignments
- Participate in Statistical Programming process improvement initiatives
- Manage timelines and ensure communication with CROs/FSPs and internal teams (programming, 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:
- Degree in Statistics, Mathematics, or Engineering
- 6+ years relevant experience (with MS) OR 8+ years relevant experience (with BS)
- Experience with SAS programming related to drug development
- Experience with regulatory filings
- Experience adhering to CDISC standards and creating/reviewing ADaM specifications

Preferred:
- Knowledge of R or Ai (not required; plus)

Other required skills:
- In-depth SAS programming concepts/techniques for drug development
- Fundamental understanding of CDISC standards and drug development process
- Ability to communicate clearly (oral and written)
- Ability to accurately estimate effort for study programming activities