Senior Biostatistician

We are seeking a Senior Biostatistician to expand the Freenome Biostatistics team. This role will support statistical study design, analysis, summarization of clinical studies to support research, development and regulatory submissions for Freenome’s in vitro diagnostic products (IVDs). The ideal candidate is passionate about biostatistics and the opportunity to have a significant impact to change the landscape of early cancer detection.

This role will report to the Principal Biostatistician. This role will be a Remote role.

• →Perform in a lead Biostatistician role and provide technical expertise as a core team member of high complexity clinical studies, including statistical oversight and attending relevant project meetings.
• →Provide advanced statistical guidance and thought leadership for innovative study design and clinical development plans, including endpoint selection, estimands, sample size and power, and analysis methods.
• →Develop the statistical sections of the study protocols, statistical analysis plans, and related documents.
• →Interpreting analysis results and conduct the overall statistical review of tables, figures, and listings to ensure accurate and consistent reporting in study reports and regulatory documents.
• →Partner with statistical programmers to establish priorities, manage timelines, review deliverable quality, and resolve issues affecting project objectives.
• →Support regulatory submissions and responses by prepareing and reviewing statistical analyses, summaries, and supporting documentation in collaboration with Regulatory, Clinical, and other stakeholders.
• →Support the preparation of abstracts, oral presentations, manuscripts and written reports by ensuring the results of clinical programs and studies are effectively communicated to internal and external stakeholders.
• →Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement).
• →Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization. 
  

• 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 including the ability to interact professionally with all organizational levels to drive achievement of deliverables.
• Strong interpersonal and relationship management skills including the ability to proactively elevate and resolve issues cross-functional to ensure project objectives are met.
• Comprehensive organizational, judgment, analytical, decision-making, and influencing skills.
• Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems.
• Ability to develop effective peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Ability to thrive in a fast paced, dynamic, and constantly changing work environment.
• Strong programming skills using  R (required) and Python (preferred). Demonstrated proficiency with literate programming (R markdown/ Sweave).

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