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Salary: USD 140,250 - 200,025 / annual
Freenome is seeking a Senior Biostatistician to join and expand its Biostatistics team. This role supports statistical study design, analysis, and summarization of clinical studies for research, development, and regulatory submissions of in vitro diagnostic (IVD) products focused on early cancer detection. The position reports to the Principal Biostatistician and is fully remote.
Key responsibilities include:
- Lead biostatistician role providing technical expertise on high-complexity clinical studies, including statistical oversight and project meeting participation
- Provide advanced statistical guidance and thought leadership for innovative study design and clinical development plans, including endpoint selection, estimands, sample size, power calculations, and analysis methods
- Develop statistical sections of study protocols, statistical analysis plans, and related regulatory documents
- Interpret analysis results and conduct statistical review of tables, figures, and listings for accurate reporting in study reports and regulatory submissions
- Partner with statistical programmers to establish priorities, manage timelines, review deliverable quality, and resolve project issues
- Support regulatory submissions and responses by preparing and reviewing statistical analyses, summaries, and supporting documentation in collaboration with Regulatory, Clinical, and other stakeholders
- Support preparation of abstracts, oral presentations, manuscripts, and written reports to communicate clinical program results to internal and external stakeholders
- Provide statistical expertise to internal and external stakeholders for presentations, publications, Marketing, and Health Economics & Reimbursement
- Create, maintain, and implement SOPs, processes, standards, and work instructions for biostatistics to ensure compliance, accuracy, efficiency, and optimization
Requirements:
- Master's degree or higher in Statistics, Biostatistics, Bioinformatics, Data Science, or Mathematics
- 6+ years of related experience with a Master's degree; or 3+ years of related experience with a PhD; or equivalent experience
- Expert understanding of biostatistics processes and systems
- Excellent written and verbal communication skills with ability to interact professionally across all organizational levels
- Strong interpersonal and relationship management skills; ability to proactively elevate and resolve cross-functional issues
- Comprehensive organizational, judgment, analytical, decision-making, and influencing skills
- Expert understanding of clinical trial design with ability to apply functional knowledge and methodologies to resolve complex problems
- Ability to develop effective peer and cross-functional relationships to maximize best practice sharing and team effectiveness
- Ability to thrive in fast-paced, dynamic, constantly changing work environment
- Strong programming skills using R (required) and Python (preferred); demonstrated proficiency with literate programming (R markdown/Sweave)
Nice to have:
- PhD degree or higher in Statistics, Biostatistics, or Mathematics
- Experience leading IVD clinical biostatistics to FDA submission
- Knowledge of CDISC requirements
