Director, Biostatistics - PK/PD

Role Summary

Director, Biostatistics - PK/PD responsible for providing strategic statistical leadership for PK/PD studies across all phases of clinical development, partnering with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs, and Clinical Development to support study design, data analysis, and regulatory submissions. Requires deep PK modeling expertise and cross-functional collaboration.

Responsibilities

• Provide strategic biostatistical leadership across all PK/PD-related studies and development programs.
• Collaborate with Clinical Pharmacology to design studies involving PK, ADME, bioavailability, and drug‚Äìdrug interactions.
• Develop and oversee statistical analysis plans (SAPs) for PK/PD endpoints, ensuring methodological rigor and execution quality.
• Conduct or supervise exploratory exposure‚Äìresponse analyses, including covariate modeling, visualization, and interpretation to inform clinical and regulatory strategy.
• Ensure high-quality, compliant, and timely delivery of statistical components for regulatory submissions (e.g., INDs, NDAs, BLAs, and global equivalents).
• Communicate statistical concepts, methods, and results clearly to both technical and non-technical audiences, including clinical, regulatory, and senior leadership teams.
• Partner with internal teams and external stakeholders‚Äîincluding CROs, consultants, and partner companies‚Äîto align on study design, analysis, and reporting.
• Establish, maintain, and continuously improve standard operating procedures (SOPs), work instructions, and processes for PK/PD data analyses to ensure consistency, compliance, and best practices across all studies and projects.
• Mentor, guide, and develop junior statisticians and contractors involved in PK/PD activities, fostering technical excellence and professional growth.

Qualifications

• Master‚Äôs Degree with at least 7+ years‚Äô experience, or Ph.D. with at least 5 years‚Äô experience

Skills

• Strong expertise in pharmacokinetic (PK) and pharmacodynamic (PD) modeling (non-compartmental and population PK).
• Experience with SAS programming, regulatory interactions, and global submissions.
• Ability to design studies involving PK, ADME, bioavailability, and drug‚Äìdrug interactions.
• Excellent communication of complex statistical concepts to diverse audiences.
• Leadership and mentoring capabilities for junior statisticians and contractors.

Education

• Master‚Äôs or Ph.D. in Biostatistics, Statistics, or a related field

Additional Requirements

• Travel: NA
• Supervisory/leadership responsibilities as outlined above