Principal Biostatistician

Precision For Medicine

. Provide statistical support for all phases of clinical development .

Posted 10/22/2026full-timeRemote • United Kingdom, Hungary, Poland, Romania, Serbia, SlovakiaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates mastery of statistical principles and advanced statistical concepts in clinical trials, with extensive experience in SAS programming and adherence to industry standards such as ICH guidelines and FDA regulations.

Highest-signal resume keywords

SAS Programming SkillsStatistical Analysis PlansClinical Trial DesignICH Guidelines KnowledgeAdvanced Statistical Concepts

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisSample Size CalculationsQuality Control for SAS ProgramsStatistical Methods DevelopmentData Analysis Datasets GenerationRandomization Schedules GenerationStatistical ReportingStatistical Sections ReviewStatistical ConsultingBudget Development

Soft Skills

Communication SkillsOrganizational SkillsProblem-Solving SkillsInterpersonal SkillsTime Management Skills

Industry Keywords

BiostatisticsClinical DevelopmentFDA GuidelinesCDISC Data Structures21 CFR Part 11Clinical Study ProtocolsData Monitoring CommitteesProject ManagementRegulatory ComplianceAdaptive-Design Calculations

About the role

Key responsibilities & impact

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

What you’ll need

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