Principal Biostatistician

🔥 0 minutes ago

🌐 United Kingdom, Hungary, +4 more countries – Remote

🇬🇧 United Kingdom – Remote 🇭🇺 Hungary – Remote 🇵🇱 Poland – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 10%

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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 support for all phases of clinical development • Write and review statistical sections of protocols • Write and review statistical analysis plans, including complex study designs • Conduct statistical analyses and present results to project teams and sponsors • Develop SAS programs for tables, listings, figures, and analysis datasets • Generate and/or verify randomization schedules • Develop and review statistical methods for clinical study protocols • Provide and/or verify sample size calculations, including advanced adaptive-design calculations • Provide input into case report form development • Develop table, figure, and listing shells • Generate analysis datasets, tables, figures, and listings for clinical trial data using SAS • Perform quality control for SAS programs and study documents • Provide or supervise programming and statistical support for supplemental, exploratory, regulatory, and ad-hoc analyses • Serve as a global biostatistical consultant to company staff • Review output across programs for consistency • Provide statistical analysis and reports to Data Monitoring Committees as the unblinded biostatistician • Review statistical sections of clinical study reports • Work with sponsors, project managers, external vendors, and study teams • Lead all statistical activities for studies within timelines • Perform project budget health reviews and review monthly invoices • Oversee projects for other biostatisticians • Assist with budget development and present at bid defense meetings • Participate in developing and maintaining departmental procedures and standards • Review study tasks against agreed budgets and identify scope changes • Perform other duties as assigned

🎯 Requirements

• 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 • Experience with SAS • Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines • Broad knowledge and superior understanding of advanced statistical concepts and techniques • Mastery of statistical principles underlying clinical trials • Mastery of SAS programming skills and familiarity with other packages • Outstanding statistical skills • Excellent consultative, organizational, time management, communication, interpersonal, problem-solving, and presentation skills • Sound judgment/decision making • Ability to establish and teach others to maintain effective working relationships with coworkers, managers and clients • Service oriented, accountable and flexible • Competency in written and spoken English • Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures