Director, Biostatistics - Genetic Medicine

Role Summary

Director, Biostatistics will lead the Biostatistics department within Global Development, guiding drug development questions, endpoint feasibility, and statistical approaches; design clinical experiments and interventional studies to generate and analyze data; and interpret results to inform decisions. The role includes representing statistical issues in regulatory meetings, developing training and new infrastructure, and mentoring junior statisticians, with potential to manage staff.

Responsibilities

• Represent Biostatistics in Strategic Project Teams and Global Clinical Sub teams.
• 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.
• Regulatory Contributions: 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.
• Process And Methodology Development: Identify gaps in processes and lead working groups to implement improvements; develop and revise SOPs; lead research teams to establish new statistical methodologies as needed.
• Communication And Training: Prepare presentations and reports to communicate statistical findings to project teams, management, and regulatory bodies; deliver training programs to enhance statistical understanding among non-statistical colleagues.
• Leadership And Mentorship: Mentor and oversee junior statisticians, ensuring adequate support for other programs; potentially manage full-time staff and oversee their professional development.

Qualifications

• Required: PhD in Statistics/Biostatistics with over 8 years of pharmaceutical industry experience (or MS with over 13 years). A PhD is strongly preferred.
• Preferred: Experience in rare disease, neurodegenerative disease, or gene therapy.
• 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.

Education

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

Additional Requirements

• This role requires onsite work four days per week; relocation assistance is available for non-local candidates.
• On-site policy and location-specific considerations will be discussed with the recruiter.