Director, Biostatistics - Obesity

Role Summary

Director, Biostatistics - Obesity. This position supports Clinical Biostatistics within Global Development, requiring a strong background in biostatistics, leadership capabilities, and the ability to contribute to drug development and regulatory strategies while fostering collaboration across teams.

Responsibilities

• Represent Biostatistics in Global Clinical Subteams.
• Partner with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical Scientists, Statistical Programming, Data Management, and Medical Writing to design and analyze clinical trials.
• Ensure clinical programs are appropriately structured for success.
• Guide staff in preparing materials for regulatory interactions, including analysis plans, tables, figures, and listings (TFLs) for submissions and advisory committee meetings.
• Co-present findings to regulatory agencies and management.
• Identify gaps in processes and lead working groups to implement improvements.
• Develop and revise SOPs and contribute to cross-functional workstreams.
• Lead research teams to establish new statistical methodologies as needed.
• Prepare presentations and reports to effectively communicate statistical findings to project teams, management, and regulatory bodies.
• Deliver training programs to enhance statistical understanding among non-statistical colleagues.
• Mentor and oversee junior statisticians, ensuring adequate support for other programs.
• Potentially manage full-time staff and oversee their professional development.

Qualifications

• PhD in Statistics/Biostatistics with over 8 years of pharmaceutical industry experience. A PhD is strongly preferred.
• MS in Statistics/Biostatistics with over 13 years of pharmaceutical industry experience.
• Preferred experience in obesity, cardiovascular, and/or metabolism.
• In-depth knowledge of drug discovery and development, with the ability to integrate statistical concepts into strategic decision-making.
• Strong leadership and influence skills, with a proven ability to collaborate effectively in cross-functional teams.
• Demonstrated critical thinking, time management, and communication skills to thrive in a fast-paced, collaborative environment.

Skills

• Statistical leadership and cross-functional collaboration
• Clinical trial design and analysis
• Regulatory submission materials development (analysis plans, TFLs)
• Regulatory interface and communication
• Training and mentorship
• Process improvement and SOP development

Education

• PhD in Statistics/Biostatistics or MS in Statistics/Biostatistics (with extensive pharmaceutical industry experience).

Additional Requirements

• None beyond qualifications listed.