Director, Biostatistics (Remote)

Brief Description :

The Director, Oncology Early Development Biostatistics is the statistical lead on Oncology Early Development Jazz Pharmaceuticals drug development projects, and will act as a statistical expert across all studies in the project(s). This position can have direct reports up to Associate Director level, participates in regulatory interactions for the project(s), provides statistical leadership for direct reports, and ensures the quality and timeliness of biostatistics analyses. Contributes to or leads development of departmental processes and procedures, including establishing standards and operating procedures. Lead statistical input and strategy in governance team discussions. This position works collaboratively with clinicians, data managers, other biostatisticians, and statistical programmers in the planning, conduct, and analysis of early phase oncology clinical studies. Oversees professional development of biostatisticians.

Essential Functions

• Lead early phase oncology drug development projects by developing and executing statistical strategy, design, and analyses for clinical trials.
• Manage biostatisticians within the drug development projects.
• Manage CROs providing statistical support to ensure timely delivery of quality analysis results; oversee contracts and invoices.
• Approve guidelines and standards of CROs to ensure quality of deliverables.
• Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices.
• Provide technical support and input to project statisticians and statistical tasks.
• Provide statistical expertise to prepare for meetings with regulatory agencies; attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies and support and defend clinical programs.
• Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data.
• Present study results to internal and external audiences.
• Develop statistical programs as necessary to simulate clinical trial design operating characteristics, simulate clinical trial design operating characteristics, perform analysis, prepare data displays, and verify the correctness of data and analyses.
• Be able to conduct independent research and resolve statistical methodological issues.
• Recruit, develop, and supervise internal and external statisticians to achieve project goals.
• May lead outsourcing statistical activities within a program.

Required Knowledge, Skills, and Abilities

Minimum Requirements

Description of Physical Demands

Description of Work Environment

FOR US-BASED CANDIDATES ONLY