Principal Biostatistician

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

📋 Description

• Provide statistical support throughout all stages of clinical development.

• Draft and review statistical sections of study protocols.

• Prepare and assess statistical analysis plans, encompassing intricate study designs.

• Perform statistical analyses and communicate results to project teams and sponsors.

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

• Generate and/or confirm randomization schedules.

• Develop and evaluate statistical methodologies for clinical study protocols.

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

• Contribute to the development of case report forms.

• Create shells for tables, figures, and listings.

• Produce analysis datasets, tables, figures, and listings for clinical trial data utilizing SAS.

• Conduct quality control for SAS programs and study-related documents.

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

• Act as a global biostatistical consultant for company personnel.

• Review outputs across programs to ensure consistency.

• Deliver statistical analysis and reports to Data Monitoring Committees in the capacity of the unblinded biostatistician.

• Review 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 project budget health reviews and assess monthly invoices.

• Supervise projects handled by other biostatisticians.

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

• Engage in the development and maintenance of departmental procedures and standards.

• Evaluate study tasks against agreed budgets and identify any scope changes.

• Perform other assigned duties.

⛳️ 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 at least 7 years of experience.

• Proficient in SAS.

• Familiarity with industry standards such as ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.

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

• Mastery of statistical principles that govern clinical trials.

• Proficient SAS programming skills and familiarity with additional software packages.

• Exceptional statistical skills.

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

• Sound judgment and decision-making capabilities.

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

• Service-oriented, accountable, and adaptable.

• Proficiency in written and spoken English.

• Adhere to and train others on relevant regulations, including FDA, ICH, and Precision Policies and Procedures.

🏝️ Benefits

• Comprehensive health benefits.

• Opportunities for professional development and growth.

• Flexible working arrangements.

• Collaborative and supportive work environment.