Principal Biostatistician
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Job Description
Principal Biostatistician supporting statistical design, analysis, and reporting for Precision for Medicine’s clinical trials. Leading SAS programming, sponsor collaboration, and global biostatistical oversight.
Responsibilities:
- 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:
- 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
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