Telecommuting Biostatistics Senior Manager in the Phildelphia Area

A medical company is seeking a Telecommuting Biostatistics Senior Manager in the Philadelphia Area.

Individual must be able to fulfill the following responsibilities:

• Provide guidelines and standards to CROs to ensure quality of deliverables
• Attend regulatory meetings to support and defend clinical programs
• Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally

Must meet the following requirements for consideration:

• MS or PhD in statistics, mathematics, or related field, with 5-8 years of experience pharmaceutical or biotechnology industries. Personify is an EOE
• Experience in contributing to NDAs or BLAs
• Excellent verbal and written communication skills, demonstrated technical leadership in delivering critical milestones, and experience interacting with regulatory agencies are required
• An ability to develop strategic partnerships with key internal stakeholders and external experts to deploy innovative statistical methodology in clinical trial design & analysis is required
• Proficient in US drug development regulatory requirements as they relate to statistics
• Must have oncology experience