Director of Biostatistics

Job Summary

A company is looking for an Associate/Director of Biostatistics, Early Phase Pharmacodynamics.

Key Responsibilities:

• Serve as a biostatistical consultant and participate as a lead biostatistician on major projects
• Support business development by developing client contacts and providing scientific/statistical support
• Maintain compliance with regulatory guidelines and develop pharmacodynamic training for teams

Required Qualifications:

• MS or PhD in Biostatistics, Pharmacology, or a related field with 7+ years of relevant experience
• Expertise in complex statistical methods for Phase 1 and 2a clinical trials
• Understanding of FDA guidelines on abuse potential and experience in this area
• Strong knowledge of SAS or R and CDISC Data Standards
• Experience in clinical research and drug development processes related to CNS-acting compounds