Principal Biostatistician/Senior Principal Biostatistician

🕒 July 30

🇨🇦 Canada – Remote

💵 $149k - $246k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Provide statistical leadership and support for all phases of clinical development • Consult with clients regarding clinical trial study design and regulatory strategy • Develop and review statistical methods for clinical study protocols • Provide and/or verify sample size calculations • Author and review statistical analysis plans for complex study designs • Review statistical output and clinical study report sections for accuracy • Generate and/or verify randomization schedules • Provide statistical analysis and reporting to Data Monitoring Committees as the unblinded reporting biostatistician • Lead complex programs such as NDA/BLA/MAA submissions and multi-protocol programs • Provide statistical oversight and serve as a subject matter expert • Work with sponsors, internal study teams, and external vendors • Develop and review procedural documents and work on new initiatives • Mentor and train other statisticians • Attend bid defense meetings for complex programs • Routinely update internal systems, including timesheets, expense reports, and financial reports

🎯 Requirements

• Senior Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 12+ years of experience; or PhD degree in Statistics, Biostatistics, or related field with 9+ years of experience • Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years of experience; or PhD degree in Statistics, Biostatistics, or related field with 7+ 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, such as Bayesian adaptive study design, survival analysis, or repeated measures • Sound knowledge of ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines • Experience with SAS • Competency in written and spoken English

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation