Director Of Biostatistics

Director Of Biostatistics Overview

• Lead as Director of Biostatistics, driving statistical excellence in pharmaceutical development.
• Collaborate with cross-functional teams to align statistical strategies with regulatory and commercial goals.
• Mentor and develop a high-performing team of statisticians, fostering professional growth.
• Represent the organization in external engagements, including regulatory bodies and industry conferences.
• Innovate statistical methodologies to enhance decision-making and product development processes.
• Ensure compliance with safety, health, and environmental standards in statistical activities.
• Contribute to strategic governance committees and regulatory submissions, influencing key decisions.
• Work effectively in a hybrid environment, balancing onsite and remote collaboration.

Director Of Biostatistics Key Responsibilities & Duties

• Develop and lead statistical strategies for product development and regulatory submissions.
• Manage and mentor a team of statisticians, ensuring excellence in output and professional growth.
• Communicate product profile benefits, risks, and uncertainties effectively to stakeholders.
• Collaborate with external partners to ensure timely and quality statistical analyses.
• Represent statistical strategy in internal governance and leadership teams.
• Promote knowledge and application of advanced statistical methodologies in the pharmaceutical industry.
• Ensure adherence to safety, health, and environmental strategies in statistical activities.
• Engage in continuous improvement initiatives to enhance statistical processes and outcomes.

Director Of Biostatistics Job Requirements

• PhD in Statistics, Biostatistics, or Mathematics with substantial statistical components required.
• Minimum of 7 years of experience in biostatistics within the pharmaceutical industry.
• Demonstrated success in leading statistical teams and delivering high-quality analyses.
• Strong technical expertise and ability to manage complex projects under pressure.
• Excellent collaboration and communication skills for cross-functional team engagement.
• Experience with regulatory requirements and statistical methodologies in pharmaceutical development.
• Proficiency in representing statistical strategies externally and at industry events.
• Ability to thrive in a hybrid work environment, balancing onsite and remote collaboration.