Principal Biostatistician

Summary

The Principal Biostatistician takes the lead on statistical projects, working collaboratively with the STATs and CDM groups to ensure high quality statistical deliverables.

Requirements

• 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

Responsibilities

• 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, review/QC ADaM specifications, assess impact of protocol amendments and DB design changes on SAP, SDTM and ADaM package, and 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.