About the role
About this opportunity: We are seeking a Staff 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 Senior Director, Biostatistics. This role will be a Remote role. What you’ll do: 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 expert level statistical guidance and thought leadership for innovative study design and clinical development plans, including endpoint selection powering. Develop the statistical sections of the study protocol for clinical studies. Responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents. Conduct overall statistical review of TFLs for clinical studies. Manage operations work with internal statistical programmers to ensure timeliness and quality of deliverables. Represent Biostatistics in interactions with regulatory authorities (e.g FDA) and during audits. 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. Must haves: Masters degree or higher in Statistics, Biostatistics or Math. 10+ years of lead project work as a statistician on clinical trial projects. 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. Proven successful project management leadership skills. Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems. Experience leading briefings and technical meetings for internal and external stakeholders. 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). Nice to haves: Ph.D degree or higher in Statistics, Biostatistics or Math. Experience leading IVD clinical Biostatistics to FDA submission. Knowledge of CDISC