Location: Head Office (Toronto, ON)

Status: Full time

Summary:

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.

📌 Senior/principal Biostatistician Toronto
🏢 SCiAN Services
📍 Toronto