Statistical Science Director

Statistical Science Director Overview

• As a Statistical Science Director, lead statistical strategies and technical activities in pharmaceutical development.
• Collaborate across functions to design, deliver, and interpret data for regulatory submissions and governance committees.
• Mentor and develop statistical staff, fostering technical expertise and professional growth within the team.
• Apply novel statistical methodologies to address complex issues and enhance decision-making processes.
• Represent the organization externally at conferences, workshops, and health authority interactions.
• Contribute to the development plans, regulatory strategies, and health technology assessments for product indications.
• Ensure statistical content quality for study designs, documents, delivery, interpretation, and submissions.
• Lead global statistical strategies and direct project work delivered by internal and external teams.
• Stay updated on statistical methodologies and implement innovative approaches in pharmaceutical research.

Statistical Science Director Key Responsibilities & Duties

• Lead statistical design and strategy for product development plans and regulatory submissions.
• Provide statistical leadership and ensure compliance with standards and regulations.
• Quantify benefit, risk, value, and uncertainty of emerging product profiles.
• Collaborate with cross-functional teams to deliver high-quality decision support.
• Mentor and coach statistical staff, promoting technical education and training.
• Partner with CROs to ensure timely and quality delivery of statistical work.
• Represent statistical strategy in internal governance and therapy area leadership teams.
• Investigate and implement novel statistical approaches for regulatory and methodological advancements.
• Maintain expertise in statistical methodologies and contribute to external collaborations and publications.

Statistical Science Director Job Requirements

• Doctorate in Statistics, Mathematics, or related field with substantial statistical components.
• Minimum 5 years of experience in clinical trials and statistical leadership.
• Proficiency in programming languages like SAS, R, and Python.
• Recognized expertise in statistical methodologies and regulatory interactions.
• Experience in vaccines and immunotherapy is preferred but not required.
• Strong project management and communication skills for cross-functional collaboration.
• Ability to lead and direct work across teams, ensuring quality and compliance.
• National recognition as a statistical technical expert with relevant publications.
• Experience in business development opportunities, such as in-licensing, is beneficial.