Senior Biostatistician

The role

This person will support statistical study design, analysis, and summarization of clinical studies for in vitro diagnostic products. They will provide technical expertise for high complexity clinical studies and support regulatory submissions.

What you will do

• Perform in a lead Biostatistician role and provide technical expertise for high complexity clinical studies.
• Provide advanced statistical guidance for innovative study design and clinical development plans.
• Develop statistical sections of study protocols, statistical analysis plans, and related documents.
• Interpret analysis results and conduct statistical review of tables, figures, and listings.
• Partner with statistical programmers to manage timelines and review deliverable quality.
• Support regulatory submissions by preparing and reviewing statistical analyses and summaries.
• Support the preparation of abstracts, oral presentations, manuscripts and written reports.
• Provide statistical expertise to internal and external stakeholders.
• Create, maintain, and implement SOPs, processes, standards, and work instructions.

Required qualifications

• Masters degree or higher in Statistics, Biostatistics, Bioinformatics, Data Science or Math.
• 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 related aspects of biostatistics processes and systems.
• Excellent written and verbal communication skills.
• Strong interpersonal and relationship management skills.
• Comprehensive organizational, judgment, analytical, decision-making, and influencing skills.
• Expert understanding of clinical trial design.
• Ability to develop effective peer, cross functional and cross business relationships.
• Ability to thrive in a fast paced, dynamic, and constantly changing work environment.
• Strong programming skills using R.
• Demonstrated proficiency with literate programming (R markdown/ Sweave).

Nice to have

• Ph.D degree or higher in Statistics, Biostatistics or Math.
• Experience leading IVD clinical Biostatistics to FDA submission.
• Knowledge of CDISC requirements

Benefits

• Equity
• Cash bonuses
• Medical benefits
• Financial benefits
• Other benefits

About the company

Freenome is an equal-opportunity employer focused on early cancer detection through in vitro diagnostic products.