Senior Statistical Advisor supporting Phase I–IV dermatology clinical trials at Indero, a contract research organization. Advising on trial design, statistical analysis, regulatory submissions, and clinical study reporting.
Responsibilities
Provide statistical input into Phase I–IV clinical trial development
Assist in protocol development
Manage and support customer relationships
Support statistical requirements for regulatory submissions
Support data analysis and interpretation
Support research and development
Conduct activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures
Respect sponsor requirements and timelines
Requirements
Provide statistical input into protocols, including trial design, sample size estimation, power calculations, randomization, and statistical methods
Communicate with clients regarding study protocol or statistical analysis issues
Review statistical analysis plans
Review clinical trial data results, validate statistical output, accurately interpret results, and communicate statistical results and concepts clearly to non-statisticians
Provide support to scientific writers working on Clinical Study Reports
Advise on the design of valid, efficient, and cost-effective clinical trials and other research projects
Provide input into statistical standard operating procedures and general standardization efforts
Collaborate effectively with clinical trial implementation teams
Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review
Required experience, qualifications, and/or adequate training for other assigned responsibilities
Work permit for Canada required
Benefits
Flexible work schedule
Permanent full-time position
Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
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