Lead Biostatistician responsible for biostatistical work that supports clinical evidence, including advanced statistical programming and complex statistical analyses.
Key duties include:
- Lead clinical trial design activities in collaboration with cross-functional stakeholders.
- Develop and manage Statistical Analysis Plans (SAPs) and ensure clinical data structures support planned analyses.
- Perform and/or oversee statistical analyses and ensure methodological rigor.
- Collaborate with Clinical Affairs, clinical investigators, and other teams to align analyses with study objectives.
- Contribute to regulatory submissions by providing validated statistical outputs and documentation.
Qualifications/skills: strong expertise in statistical programming, complex analyses, clinical trial design, and SAP development; ability to partner effectively across scientific and regulatory teams and translate study goals into robust analytical strategies.