Sr. Manager, Statistical Programming
Ipsen
Overview
As Senior Manager, you will lead statistical programming for multiple compounds and studies within a therapeutic area, delivering high-quality outputs on time, either in-house or via CROs. You will oversee global regulatory submission prep and respond to health authority questions, while advancing programming standards. You’ll manage outsourced work to meet quality, budget, and timelines and contribute to robust documentation and audit readiness. You’ll drive process improvements and adopt cutting-edge approaches to complex study designs.
Responsibilities- Lead the quality and timeliness of all programming deliverables for designated studies (in-house or outsourced)
- Ensure consistent processes and excellence in execution for the studies
- Oversee programming preparation for global regulatory submissions and health authority responses
- Oversee outsourced programming to maintain quality, budget, and timeline
- Ensure deliverables include Tables, Listings, Figures, datasets and DEFINE.XML with proper documentation
- Develop and implement SAS programming standards, SOPs and validation/documentation
- Maintain study-related documentation in Ipsen-compliant audit-ready state
- Identify and implement ways to improve workflows and adapt to evolving study designs
- Proficiency in SAS programming
- Familiar with CDISC (SDTM/ADaM)
- Experience in reporting and TFL programming
- 8+ years of programming experience in pharma/biotech/CRO environments
- English language proficiency
- Knowledge of NDA/sNDA submissions (preferred)
- R or other packages (preferred)
- Experience with regulatory submissions (preferred)
- Collaborative mindset with cross-functional teams
- Strong stakeholder management and coaching instinct
- Accountability and ownership of decisions
- SAS programming
- CDISC standards (SDTM/ADaM)
- TFL programming
Reference: WJ-747_30140011