Principal Biostatistician

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Deliver statistical support throughout all stages of clinical development.

• Draft and assess statistical components of protocols.

• Create and evaluate statistical analysis plans, encompassing complex study designs.

• Execute statistical analyses and communicate findings to project teams and sponsors.

• Develop SAS programs for tables, listings, figures, and analysis datasets.

• Generate or confirm randomization schedules.

• Formulate and review statistical methodologies for clinical study protocols.

• Provide or validate sample size calculations, including advanced adaptive-design computations.

• Contribute to case report forms.

• Author statistical analysis plans and templates for tables, figures, and listings.

• Review analysis plans created by other biostatisticians.

• Produce analysis datasets, tables, figures, and listings using SAS.

• Conduct quality control for SAS programs and study documents.

• Offer or oversee programming and statistical support for various analyses, including supplemental, exploratory, regulatory, and ad hoc tasks.

• Act as a global biostatistical consultant for company personnel.

• Review outputs across programs for consistency.

• Provide statistical analyses and reports to Data Monitoring Committees as the unblinded biostatistician.

• Assess statistical sections of clinical study reports.

• Collaborate with sponsors, project managers, external vendors, and study teams.

• Lead all statistical activities for studies while adhering to timelines.

• Conduct budget health reviews and assess monthly invoices.

• Supervise projects involving other biostatisticians.

• Assist in budget development and present at bid defense meetings.

• Create and uphold departmental procedures and standards.

• Review study tasks against agreed budgets and pinpoint scope changes.

• Execute other assigned responsibilities.

⛳️ Requirements

• Master’s degree or equivalent in Statistics, Biostatistics, or a related field with over 10 years of experience; or a PhD in Statistics, Biostatistics, or a related field with over 7 years of experience.

• Proficiency with SAS.

• Familiarity with ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA regulations.

• Extensive knowledge and a superior grasp of advanced statistical concepts and techniques.

• Deep understanding of the statistical principles underpinning clinical trials.

• Expertise in SAS programming skills and familiarity with other statistical software packages.

• Exceptional statistical abilities.

• Strong consultative, organizational, time management, communication, interpersonal, problem-solving, and presentation skills.

• Sound judgment and decision-making capabilities.

• Ability to establish and guide others in maintaining effective working relationships with colleagues, managers, and clients.

• Service-oriented, accountable, and adaptable.

• Proficiency in written and spoken English.

• Capability to follow and instruct others on relevant regulations, including FDA, ICH, and Precision policies and procedures.

• Candidates must possess legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.

• AI-generated application insights with an opt-out option.

• Employment available without employer sponsorship for legally authorized candidates.