Senior Statistical Analyst - Programmer (Hybrid)

Responsibilities:
- Lead statistical programming activities and provide programming/documentation support for multiple Phase I-IV clinical studies.
- Review statistical analysis plans for assigned studies and integrated summaries; provide comments to study biostatistician.
- Create ADaM data set specifications and develop ADaM datasets for assigned studies and integrated summaries.
- Ensure analyses follow standard templates and specifications.
- Contribute to submission support and urgent regulatory agency request support.
- Follow timelines, coordinate own task assignments, and manage timelines/communication with CROs/FSPs and internal teams.
- Oversee programming tasks for a single study.
- Conduct high-level review of CRO/FSP deliverables for quality/accuracy.
- Participate in Statistical Programming process improvement initiatives.

Qualifications:
- Degree in Statistics, Mathematics, or Engineering.
- 6+ years relevant experience (with MS) OR 8+ years (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 (plus).

Other required skills:
- In-depth SAS programming concepts/techniques for drug development.
- Fundamental understanding of CDISC standards and the drug development process.
- Clear oral and written communication.
- Ability to accurately estimate effort for study-related programming activities.

Benefits (explicitly stated):
- Paid time off; medical/dental/vision insurance; 401(k) for eligible employees; short-term incentive programs eligible.