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 20%

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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 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 or verify randomization schedules • Develop and review statistical methods for clinical study protocols • Provide or verify sample size calculations, including advanced adaptive-design calculations • Provide input into case report forms • Author statistical analysis plans and table, figure, and listing shells • Review analysis plans prepared by other biostatisticians • Generate analysis datasets, tables, figures, and listings 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 analyses 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 budget health reviews and review monthly invoices • Oversee projects for other biostatisticians • Assist with budget development and present at bid defense meetings • Develop and maintain 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; or PhD degree in Statistics, Biostatistics, or related field with 7+ years experience • Experience with SAS • Knowledge of 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 and 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 • Ability to follow and train others on applicable regulations, including FDA, ICH, and Precision policies and procedures • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities • AI-generated application insights with opt-out option • Employment without employer sponsorship for legally authorized candidates