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
