Role Summary
Director, Biostatistics – Genetics Medicine role at Regeneron within Global Development. Requires a strong biostatistics background, exceptional leadership, and the ability to contribute to drug development and regulatory strategies while fostering cross-functional collaboration and innovation. This position is a four-day onsite opportunity each week, with potential relocation support for non-local candidates.
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
- Guide staff in preparing regulatory materials, including analysis plans, tables, figures, and listings 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 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
- Required: PhD in Statistics/Biostatistics with over 8 years of pharmaceutical industry experience (or MS in Statistics/Biostatistics with over 13 years); PhD strongly preferred
- Preferred: Experience in rare disease, neurodegenerative disease, or gene therapy
- Required: In-depth knowledge of drug discovery and development, with the ability to integrate statistical concepts into strategic decision-making
- Required: Strong leadership and influence skills, with a proven ability to collaborate effectively in cross-functional teams
- Required: Demonstrated critical thinking, time management, and communication skills to thrive in a fast-paced, collaborative environment
Education
- PhD in Statistics or Biostatistics; or MS in Statistics/Biostatistics with extensive pharmaceutical industry experience as described above