Job Summary
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
