Senior Statistical Analyst - Programmer (Hybrid)

Responsibilities:
- Lead statistical programming activities and provide programming/documentation support for multiple Phase I-IV studies.
- Review statistical analysis plans for assigned studies/integrated summaries and provide comments to the study biostatistician.
- Create ADaM data set specifications and ADaM datasets.
- Ensure study analysis is consistent with standard templates/specifications.
- Contribute to submission support and urgent regulatory agency requests.
- Follow timelines; coordinate own tasks.
- Participate in Statistical Programming process improvement initiatives.
- 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.
- Perform high-level review of CRO/FSP deliverables for quality/accuracy.

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; create/review ADaM specifications.

Preferred:
- Knowledge of R or Ai is a 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/written communication.
- Ability to estimate effort for study-related programming activities.

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