Description:
The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.
Responsibilities
- Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development
- Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs
- Serve as primary author for statistical sections of protocol
- Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells)
- Participate in development of EDC database and interactive response technology (IxRS) specifications
- Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions
- Implement innovative statistical techniques that will provide benefit to clinical development programs
- Contribute to strategic planning and go/no go decision guidance
- Review biostatistics and statistical programming tasks outsourced to vendors
- Perform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if needed
- Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if needed
- Ensure timeliness and quality of deliverables
- Travel as needed to execute assigned responsibilities.