Location: Head Office (Toronto, ON)
Status: Full-Time
The Senior / 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 5 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/resource allocation of statistical deliverables
- Author Statistical Analysis Plans
- Author/Contribute to Randomization, Sample Size Calculation and Statistical Methods section of protocols
- Responsible for development of ADaM package:
- Author or review/QC ADaM specifications
- Assess impact of protocol amendments and DB design changes on SAP, SDTM and ADaM package
- Review/QC ADaM datasets programmed by STAT team
- Review draft and production statistical output, responsible for quality and consistency of output across multiple cycles
- Recommend statistical methodology to analysis of clinical trial data
- Author statistical reports, contribute to the Clinical Study Report, abstracts, manuscripts and other medical communication
- Act as Biostatistician on DSMBs, SMCs and IDMCs
- Trouble-shoot complex statistical issues and make recommendations
- Assure quality of personal work.
