Job Description
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):
- <...