A large Biotech company is looking to hire a Director of Stat Programming. Hire would be responsible for all programming as well as supporting the clinical development programs directly. The Director would be a key component in designing new stat programming protocols for clinical programs and working to lead global health outcome efforts and regulatory submissions.
Key Responsibilities:
- Serving as the leader for the advisory committee meetings with the FDA/EMA
- Oversee all programming teams
- -Provide operational programming expertise during all stages of the clinical trial programs
- Oversee Stat Programming TAU lead and assist with implementation of new strategies for indication and disease area
- Act as an active member for the protocol development team with guidance and statistical insight
- Writing and reviewing SAP as well as SOP's and statistical protocols
- Contributing to vendor section and management
- Oversee all SDTM/ADaM data sets
Ideal skill set:
- 10+ years stat programming with life science knowledge preferred
- 7+ years in managing stat programming teams
- Phase I-IV clinical trial experience
- Influencing skills in a cross functional environment
- Familiarly with CDISC regarding FDA/EMA regulations and submissions
- Advanced degree highly preferred
- Confident in their written and communication skills