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):