Associate Director Civil Structural Engineer at AtkinsRéalis leading technical design work on complex multi - disciplinary projects. Working in Energy, Defence, and Nuclear sectors with opportunities for career development.
About the role
- Senior Director, Biostatistics leading strategic initiatives in the Immunology and Inflammation therapeutic area at Regeneron. Involves mentoring, compliance oversight, and collaboration with clinical teams.
Responsibilities
- Drive strategic and operational activities in the Immunology and Inflammation therapeutic area
- Assist the Head, Biostatistics in the development and implementation of departmental scientific policies, operational guidelines, and administrative structure
- Serve as senior research expert
- Provide statistical support for creation of clinical development plans, study design, and operational aspects
- Ensure statistical representation in key project decisions and regulatory meetings
- Oversee process for statistical reporting
- Review critical documents, such as SAP, analysis results presentations, CSR, and integrated summaries
- Ensure compliance with data submission guidelines
- Plan and track project activities, timelines, and resource use
- Provide justification for planned resource needs
- Encourage personal development in the context of project work
- Recruit, develop, and retain high quality staff
Requirements
- Ph.D. in statistics or related discipline with 10+ years of experience (or MS in statistics or related discipline with 15+ years) in the biotechnology, pharmaceutical or health related industry
- Significant interaction with both FDA and EMEA
- History of successful project and people management (6+ years)
- Expertise in multiple therapeutic areas
- Active research interests in area related to clinical trial
- Ability to work independently – self‐directed, high energy and strong work ethic
- High degree of creativity, latitude and attention to detail required
- Demonstrated strong leadership, project management, teamwork and interpersonal skills
- Excellent presentation skills
- Broad knowledge and superior understanding of advanced statistical concepts and techniques
- Thorough knowledge of pharmaceutical clinical development and life cycle management; ability to innovatively apply technical principles, theories and concepts to clinical drug development leading to regulatory approvals
- Thorough working knowledge of regulatory guidelines on drug development, regulatory submissions, and statistical practice
Benefits
- Health and wellness programs (including medical, dental, vision, life, and disability insurance)
- Fitness centers
- 401(k) company match
- Family support benefits
- Equity awards
- Annual bonuses
- Paid time off
- Paid leaves (e.g., military and parental leave)
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