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; comment with the study biostatistician.
- Create ADaM data set specifications and develop ADaM datasets for assigned studies and integrated summaries.
- Ensure analyses follow standard templates/specifications.
- Support submissions and urgent regulatory agency requests.
- Meet study task timelines; coordinate own tasks.
- Participate in statistical programming process improvement initiatives.
- Manage timelines and communicate with CROs/FSPs and internal stakeholders (programming, 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 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 (not required; plus).

Other Required Skills:
- In-depth SAS programming knowledge for drug development.
- Fundamental CDISC standards knowledge.
- Fundamental understanding of the drug development process.
- Clear oral and written communication.
- Ability to estimate effort for study programming activities.

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