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General Description:

The Director of Biostatistics will provide strategic statistical leadership for pharmacokinetic (PK) and pharmacodynamic (PD) studies across all phases of clinical development. This role partners closely with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs, and Clinical Development to ensure robust study design, insightful data analysis, and timely support for global regulatory submissions. Deep expertise in PK modeling, including non-compartmental and population PK analysis, and experience with regulatory interactions are essential. Experience in relevant disease areas—particularly oncology, immunology, or inflammation—is preferred. The position requires effective cross-functional collaboration with clinical teams, SAS programming, data management, clinical operations, medical writing, and other key stakeholders.

Essential Functions of the job:

•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–drug interactions.

• Develop and oversee statistical analysis plans (SAPs) for PK/PD endpoints, ensuring methodological rigor and execution quality.

• Conduct or supervise exploratory exposure–response 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—including CROs, consultants, and partner companies—to 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.Top of Form

• Mentor, guide, and develop junior statisticians and contractors involved in PK/PD activities, fostering technical excellence and professional growth.

Supervisory Responsibilities:

+ NA

Travel:

+ NA

Qualifications:

+ Master’s Degree with at least 7+ years’ experience, or Ph.D. with at least 5 years’ experience

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.