Biostatistics Director

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Biostatistics Director

We are seeking a skilled Biostatistics Director to oversee the biostatistics function for our expanding clinical development portfolio. In this strategic role, you will provide statistical insights for drug development planning, including innovative study designs and regulatory submissions. You will work collaboratively across teams to ensure the highest quality data deliverables and compliance with regulatory standards.

Key Responsibilities

• Lead and manage the biostatistics function, aligning it with company goals and clinical objectives.
• Foster a culture of collaboration and innovation within the biostatistics team.
• Provide strategic input on product development, including study design and statistical methodologies.
• Oversee the preparation and review of clinical data documentation.
• Act as the primary contact for outsourced biostatistics activities, ensuring quality and timely deliverables.
• Optimize biometric processes to enhance efficiency and maintain industry best practices.
• Collaborate with cross-functional teams to ensure well-designed and statistically valid clinical trials.
• Develop and review statistical analysis plans and reporting displays.
• Manage statistical programming resources to ensure high-quality analysis.
• Establish standard operating procedures and guidelines for the biostatistics team.
• Stay current with advancements in statistics and drug development.

Qualifications

• PhD in Statistics/Biostatistics with at least 15 years of experience in clinical development and reporting within the biotech or pharmaceutical industry.
• Proven experience interacting with regulatory authorities and handling submission processes.
• Strong understanding of CDISC submission requirements and biostatistical deliverables.
• Comprehensive knowledge of statistical methodologies in clinical trial design and analysis.
• Proficient programming skills in SAS or R are preferred.
• Excellent interpersonal skills for effective collaboration with colleagues and external partners.
• Willingness to travel occasionally as required.