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Lead Statistician

Company: Penfield Search Partners Ltd
Location: San Francisco
Posted on: January 16, 2022

Job Description:

Our client is a leading precision Oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Their proprietary platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. With their liquid biopsy-based tests for advanced stage cancer patients which aim to address the needs of early-stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection, they hope to provide patients with greater access to life-extending precision treatments. Your work will be critical in the verification and validation of in-vitro diagnostic and companion diagnostic products, leading to regulatory approvals. In this role, you will see the impact of your work quickly and at scale.

You will:
- - - - - - -Provide biostatistical insight and guidance to regulatory strategy and problem-solving
- - - - - - -Author materials for statistical analysis plans and study reports, design pilot and formal studies, and provide statistical support for regulatory and biopharmaceutical partner interactions
- - - - - - -Identify and develop appropriate statistical methods to meet real-world company needs, e.g., to characterize product performance, and communicate them clearly to internal and external stakeholders as well as regulatory agencies
- - - - - - -Be a member of the highly collaborative Biostatistics Shared Service Core of the -Corporate Core Bioinformatics team
- - - - - - -Strengthen product development and validation efforts by sharing your expertise in biostatistics, data analysis, analytical validation and experimental design in collaborative settings that include Bioinformatics, Operations, Regulatory Affairs, QA, and Software Engineering

Responsibilities:
--- - - - - - - - - -Identify appropriate statistical methods to describe and validate technologies leading to regulatory approvals; develop novel statistical methods when necessary
--- - - - - - - - - -Contribute and guide statistical content for protocols and reports in collaboration with Bioinformaticists and assay development scientists; design and defend analytical experiments with clinical and contrived samples
--- - - - - - - - - -Guide and/or conduct feasibility analyses, including simulations drawing from a rich database of historical test results
--- - - - - - - - - -Identify and solve problems proactively as needed; work with Bioinformaticists and Molecular Biologists to troubleshoot and analyze verification and validation experiments as part of FDA PMA and other regulatory submissions
--- - - - - - - - - -Clearly and succinctly communicate statistical solutions and rational to non-statistical internal and external stakeholders and regulatory authorities

Requirements:
--- - - - - - - - - -PhD with 4+ years of relevant experience in Pharmaceutical, Biotech or Diagnostic industry
--- - - - - - - - - -PhD-level experience with experimental design and associated statistical analysis (e.g., hypothesis testing, regression, hierarchical models) is required; ability to understand relationships between variables in complex assays and their effects on observed data is required; familiarity with NGS workflows and data analytic methods is strongly preferred
--- - - - - - - - - -Attention to detail, with the ability to develop and write clear, concise, complete statistical analysis plans and reports
--- - - - - - - - - -Deep interest and active curiosity in improving statistical methods and practices in support of biomedical technologies and NGS workflows
--- - - - - - - - - -Desire to contribute to personalized medicine and innovative cancer care
--- - - - - - - - - -Experience with either R or Python

Preferred Skills & Knowledge:
--- - - - - - - - - -Commitment to reproducible research is required; previous experience working in accordance to a quality system in a regulated environment
--- - - - - - - - - -Knowledge of CLSI and other guidelines for validation of diagnostic tests and experience developing or validating tests or devices in a regulated environment
--- - - - - - - - - -Molecular diagnostics experience, especially involving NGS
--- - - - - - - - - -IVD and/or Companion Diagnostic (CDx) development experience
--- - - - - - - - - -Experience troubleshooting, maintaining, and launching of a medical product
--- - - - - - - - - -Experience working in a collaborative team science environment is required; experience collaborating with Bioinformaticists is strongly preferred

Keywords: Penfield Search Partners Ltd, San Francisco , Lead Statistician, Other , San Francisco, California

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