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 lead biostatistician on major projects
• Develop new contract awards for complex phase I studies and support scientific innovation
• Maintain compliance with regulatory guidelines and conduct pharmacodynamic training

Required Qualifications:

• MS or PhD in Biostatistics, Pharmacology, or related field with 7+ years of relevant experience
• Expertise in complex statistical methods for Phase 1 and 2a clinical trials
• Strong understanding of regulatory guidelines and FDA Guidance on Abuse Potential of Drugs
• Proficient in SAS or R and knowledgeable in CDISC Data Standards
• Ability to collaborate effectively with clinical and drug development experts