Principal Biostatistician/Senior Principal Biostatistician

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🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $147.3k - $243k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Provides statistical leadership and support for all phases of clinical development • Consulting with clients regarding clinical trial study design and regulatory strategy • Developing and reviewing statistical methods of clinical study protocols • Providing and/or verifying sample size calculations • Authoring statistical analysis plans of complex study design • Reviewing statistical analysis plans written by other biostatisticians • Reviewing statistical output to ensure accuracy • Reviewing statistical sections of clinical study reports • Generating and/or verifying randomization schedules • Providing statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician • Working proactively with sponsors, internal study team, and external vendors • Serving as a Subject Matter Expert (SME) and developing/reviewing procedural documents and working on new initiatives • Providing mentoring and training to other statisticians • Attending bid defense meetings for complex programs

🎯 Requirements

• Senior Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 12+ years of experience; 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 experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years 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

🏖️ Benefits

• discretionary annual bonus • health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation