Description
We are seeking a Principal Biostatistician-FSO to join our Clinical Solutions team. As a Principal Biostatistician-FSO, you will lead biostatistical activities across Phase I-IV clinical studies.
Key Responsibilities:
- Lead biostatistical activities across Phase I-IV clinical studies
- Develop and review protocols, Statistical Analysis Plans (SAPs), mock shells, and study reports
- Provide statistical expertise for study design, sample size calculations, endpoint selection, and data interpretation
- Collaborate with sponsor representatives, statistical programmers, data management, medical writers, and clinical teams
- Review and validate statistical outputs, tables, listings, and figures (TLFs)
- Support regulatory submissions and interactions with global health authorities
- Manage multiple studies and priorities while ensuring quality and on-time delivery
- Mentor and provide technical guidance to statisticians and cross-functional team members
- Contribute to process optimization, innovation, and continuous improvement initiatives
We offer a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.