Principal Biostatistician/Senior Principal Biostatistician
New
P
Precision for MedicineBiostatistics
Remote, CanadaFull-TimePrincipal
SalarySalary Range: 147,300 - 243,000 USD (also listed as 149,000-246,000)
Apply NowOpens the employer's application page
Job Details
- Languages
- English
- Experience
- 7-12+ years depending on degree level
Requirements
- Master's degree or equivalent in Statistics, Biostatistics, or related field with 10-12+ years of experience
- PhD degree in Statistics, Biostatistics, or related field with 7-9+ years of experience
- Broad experience with regulatory submissions
- Extensive experience consulting with clients regarding clinical trial study design and regulatory strategy
- Superior understanding of a statistical methodology (e.g., Bayesian adaptive study design, Survival analysis, Repeated measures)
- Sound knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Experience with SAS
- Competency in written and spoken English
Responsibilities
- Consult with clients regarding clinical trial study design and regulatory strategy
- Develop and review statistical methods of clinical study protocols
- Provide and/or verify sample size calculations
- Author statistical analysis plans of complex study design
- Review statistical analysis plans written by other biostatisticians
- Review statistical output to ensure accuracy
- Review statistical sections of clinical study reports
- Generate and/or verify randomization schedules
- Provide statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician
- Provide mentoring and training to other statisticians
View Full Description & ApplyYou'll be redirected to the employer's site
