Principal Biostatistician
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Job Description
Principal Biostatistician supporting clinical-trial development at Precision Medicine Group, a life-sciences consultancy. Leading statistical analyses, SAS programming, study oversight, and sponsor collaboration.
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 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:
- 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:
- 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
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