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Precision Medicine Group seeks a Principal Biostatistician to provide comprehensive statistical support across all phases of clinical development. This is a senior individual contributor role with company-wide scope and mentoring responsibilities.
Key Responsibilities:
- Write and review statistical sections of clinical trial protocols and statistical analysis plans (SAPs), including complex and late-phase study designs
- Conduct statistical analyses, generate randomization schedules, and perform sample size calculations (including adaptive designs)
- Develop and maintain SAS programs for tables, listings, figures, and analysis datasets in accordance with company and sponsor procedures
- Provide input on case report form (CRF) development and quality control for statistical outputs and study documents
- Serve as unblinded biostatistician for Data Monitoring Committees (DMCs), providing statistical analysis and reports
- Lead all statistical activities for assigned studies within established timelines
- Oversee statistical work performed by other biostatisticians and provide consultative support to company staff globally
- Interact directly with sponsors, project managers, and external vendors on statistics-related project components
- Perform budget health reviews, manage monthly invoices, and assist with budget development and bid defense presentations
- Participate in development and maintenance of departmental procedures, templates, SOPs, and work instructions
- Review study tasks to ensure alignment with agreed budgets and identify scope changes
The role requires deep expertise in clinical trial statistics, regulatory knowledge, and the ability to mentor and guide junior biostatisticians while maintaining independent technical excellence.
Requirements:
- Master's degree in Statistics, Biostatistics, or related field with 10+ years of experience; OR PhD in Statistics, Biostatistics, or related field with 7+ years of experience
- Proficiency with SAS programming
- Knowledge of industry standards: 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
- Excellent consultative, communication, organizational, and presentation skills
- Competency in written and spoken English
Preferred Qualifications:
- Experience with Oncology and rare diseases
- Broad experience with late-phase studies and/or regulatory submissions
- Experience consulting with clients on study design
- Superior understanding of specific therapeutic areas or statistical methodologies (e.g., adaptive design, missing data handling)
- Familiarity with statistical packages beyond SAS
