Senior Manager, Biostatistics - Remote

Overview

The Senior Manager of Biostatistics at Ipsen is responsible for providing comprehensive statistical support and contributing strategically to clinical project decisions.

In Short

• Lead statistical support for clinical development programs.
• Focus on study design and protocol development.
• Conduct sample size calculations and simulations.
• Prepare statistical analysis plans and oversee data quality reviews.
• Collaborate with cross-functional teams and external partners.
• Ensure adherence to regulatory requirements and CDISC standards.
• Manage contract resources and CRO collaborations.
• Utilize advanced statistical methods for innovative trial designs.
• Communicate effectively with key opinion leaders and stakeholders.
• Drive regulatory submissions and maintain high-quality standards.

Requirements

• Master's degree with 15+ years of industry experience.
• Ph.D. in Biostatistics or Statistics preferred.
• Expertise in SAS and R programming.
• Strong knowledge of statistical theory and methods.
• Excellent verbal and written communication skills.
• Proficiency in MS Office (Word, Excel, PowerPoint).
• Sound understanding of GCP, ICH, and CDISC regulations.
• Problem-solving and strategic-thinking capabilities.
• Ability to work collaboratively in a team environment.
• Proactive issue identification and resolution skills.

Benefits

• Comprehensive employee benefits package.
• 401(k) with company contributions.
• Medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Parental leave and paid time off.
• Discretionary winter shutdown.
• Well-being allowance and commuter benefits.
• Short-term incentives program participation.
• Opportunities for personal and professional growth.