Proclinical is seeking a Principal Biostatistician. The successful candidate will be responsible for the complex statistical outputs, developing SAPs, and leading statistical reporting efforts. This role involves collaborating with global teams and supporting regulatory interactions.
Responsibilities:
1. Develop macros for statistical analyses.
2. Coordinate with clients to propose alternative or additional analyses.
3. Perform quality control of statistical analysis plans and related documentation.
4. Hold review processes with medical writing and other stakeholders.
5. Write statistical sections of protocols and conduct independent protocol reviews.
6. Manage project deliverables and ensure adherence to CDISC standards.
7. Coordinate clinical interpretation meetings and distribute interim analyses.
8. Ensure compliance with Good Clinical Practice and regulatory requirements.
9. Lead statistical research initiatives and deliver company-wide training.
10. Act as a Study Project Lead, managing resources and timelines.
Key Skills and Requirements:
11. Advanced degree (PhD or MSc) in Biostatistics or related discipline.
12. Strong understanding of clinical trial design and implementation.
13. Familiarity with Good Clinical Practice (GCP) and regulatory requirements.
14. Excellent teamwork and communication skills.
15. Ability to manage multiple projects and prioritize quality in all activities.