Principal Biostatistician/Senior Principal Biostatistician

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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

• 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 • Mentoring and training other statisticians • Attending bid defense meetings for complex programs • 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; 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

• This role is also eligible for a discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation