Director, Biostatistics - PK/PD

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].