Principal Biostatistician

Precision Medicine Group

. 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 expertise in statistical analysis and SAS programming, with a strong understanding of clinical trial methodologies and regulatory guidelines. Capable of leading statistical activities, providing consultative support, and ensuring compliance with ICH and FDA standards.

Highest-signal resume keywords

SAS Programming SkillsStatistical AnalysisClinical Trial MethodologiesICH Guidelines KnowledgeAdvanced Statistical Concepts

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical Analysis PlansSample Size CalculationsStatistical ProgrammingData Monitoring Committees ReportingQuality Control for SAS ProgramsStatistical Methods DevelopmentRandomization Schedules GenerationStatistical Sections ReviewAnalysis Datasets GenerationBudget Development

Soft Skills

Consultative SkillsOrganizational SkillsTime ManagementCommunication SkillsProblem-Solving Skills

Industry Keywords

BiostatisticsClinical DevelopmentFDA GuidelinesCDISC Data Structures21 CFR Part 11Clinical Study ProtocolsAdaptive-Design CalculationsEffective Working RelationshipsPresentation SkillsService-Oriented

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 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

What you’ll need

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

Comp & perks

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