Principal Biostatistician/Senior Principal Biostatistician

🕒 July 30

🇺🇸 United States – Remote

💵 $147.3k - $243k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 18%

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 For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 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 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 • Lead complex programs such as NDA/BLA/MAA submissions or multi-protocol programs and provide statistical oversight • Work with sponsors, internal study teams, and external vendors • Serve as a subject matter expert, develop/review procedural documents, and work on new initiatives • Mentor and train other statisticians • Attend bid defense meetings for complex programs • Maintain internal systems such as 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