Senior Biostatistician

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $140.3k - $200k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Freenome

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

🤖 Artificial Intelligence

💰 $290M Corporate Round on 2022-01

Healthcare • Biotechnology • Artificial Intelligence

Freenome is a company focused on advancing early cancer detection through the integration of scientific innovation and artificial intelligence. Their platform uses multiomics technology to identify cancer at its most treatable stages, enabling early intervention. The company emphasizes a standard blood draw method for ease of use, aiming to redefine cancer screening. Freenome is driven by a robust clinical research program and is committed to discovering, developing, and validating early cancer detection tests, employing a multidisciplinary team dedicated to pushing the boundaries of what's possible in cancer diagnostics.

📋 Description

• 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 study protocols, statistical analysis plans, and related documents. • Interpret 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 preparing and reviewing statistical analyses, summaries, and supporting documentation with Regulatory, Clinical, and other stakeholders. • Support preparation of abstracts, oral presentations, manuscripts, and written reports. • Provide statistical expertise to internal and external stakeholders, including presentation/publication, Marketing, and Health Economics & Reimbursement. • Create, maintain, and implement biostatistics SOPs, processes, standards, and work instructions.

🎯 Requirements

• 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 (nice to have). • Experience leading IVD clinical Biostatistics to FDA submission (nice to have). • Knowledge of CDISC requirements preferred.

🏖️ Benefits

• Equity • Cash bonuses • Full range of medical, financial, and other benefits • Equal-opportunity employer and diversity commitment