Principal Biostatistician (Clinical Trials)

Location: London, England, UK; or remote from Hungary, Poland, Romania, Serbia, or Slovakia. Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Company

hirify.global provides clinical development and related statistical services to sponsors.

What you will do

• Provide statistical support across all phases of clinical development, including protocol methods, sample size calculations, randomization schedules, statistical analysis plans, and complex study designs.
• Conduct clinical trial analyses and develop SAS programs for analysis datasets, tables, listings, and figures.
• Lead statistical activities within timelines and provide reports to project teams, sponsors, regulatory agencies, and Data Monitoring Committees as an unblinded biostatistician.
• Work directly with sponsors, project managers, external vendors, and study teams on statistics-related project components.
• Perform quality control, review statistical documents and outputs, and oversee statistical work performed by other biostatisticians.
• Review project budgets and invoices, support budget development and bid defense meetings, and identify changes in scope.

Requirements

• Master's degree or equivalent in Statistics, Biostatistics, or a related field with 10+ years of experience, or a PhD degree in Statistics, Biostatistics, or a related field with 7+ years of 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 and SAS programming skills, with familiarity with other packages.
• Excellent consultative, organizational, communication, interpersonal, problem-solving, and presentation skills, including time management and workload coordination.
• Sound judgment, decision-making ability, accountability, flexibility, and the ability to establish and teach effective working relationships.
• Competency in written and spoken English and the ability to follow and train others on applicable regulations and company procedures.

Nice to have

• Experience in oncology and rare diseases.
• Broad experience with late-phase studies and/or submissions.
• Experience consulting with clients on study design.
• Superior understanding of a specific therapeutic area and/or statistical methodology, such as adaptive design or missing data.

Culture & Benefits

• Work with global company staff, sponsors, project managers, study teams, and external vendors.
• Participate in developing and maintaining departmental procedures, standards, templates, SOPs, and work instructions.
• Provide statistical consultation to company staff across regions.