Senior Statistical Analyst - Programmer (Hybrid)

Senior Statistical Analyst

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 and provide comments to the study biostatistician
- Create ADaM dataset specifications and datasets for assigned studies and integrated summaries
- Ensure study analysis aligns with standard templates and specifications
- Support submissions and urgent regulatory agency requests
- Follow timelines for assigned study tasks; coordinate own task assignments
- Participate in statistical programming process improvement initiatives
- Manage timelines and ensure communication with CROs/FSPs and internal partners (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 Qualifications:
- Knowledge of R or AI (not required but a plus)

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

Benefits:
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k)

Application instructions:
- Not provided in the text.