Principal Biostatistician / Senior Principal Biostatistician

🕒 July 30

🇺🇸 United States – Remote

💵 $147.3k - $243k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 25%

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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 statistical analysis plans for complex study designs • Review statistical analysis plans written by other biostatisticians • Review statistical output for accuracy • Review statistical sections of clinical study reports • Generate and/or verify randomization schedules • Provide statistical analysis and reporting to Data Monitoring Committees as the unblinded reporting biostatistician • Work proactively with sponsors, internal study teams, and external vendors • Serve as a subject matter expert and develop/review procedural documents and new initiatives • Provide mentoring and training to other statisticians • Attend bid defense meetings for complex programs • Lead complex programs such as NDA/BLA/MAA submissions or multi-protocol programs and provide statistical oversight • Perform other duties as assigned

🎯 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 • Ability to follow and train others on applicable regulations, including FDA, ICH, and Precision policies and procedures • Ability to routinely update internal systems, including timesheets, expense reports, and financial reports

🏖️ Benefits

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