Summary: The
Principal Biostatistician takes the lead on statistical projects, working collaboratively with the STATs and CDM groups to ensure high quality statistical deliverables. We are looking for someone who has: MSc. or PhD. in Biostatistics, Statistics or related field Minimum 7 years experience as a Biostatistician in Pharma/Biotech Industry. CRO experience as asset Therapeutic experience in Oncology, CNS and orphan drug indications Proven experience leading Statistical Projects In-depth knowledge and application of CDISC, SDTM and ADaM submissions In-depth knowledge of FDA and ICH regulations and guidelines Excellent written and verbal communication skills Cooperative and team-oriented Self-motivated and detailed-oriented Ability to work to tight deadlines while maintaining high standards
What you will be doing (Project-by-project basis): Act as the Lead Biostatistician / Project Manager Interface with Sponsor: collect requirements, determine timelines/resour...