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Lead Biostatistician

🕒 il y a 16 jours

🇩🇪 Allemagne – Télétravail

💵 $162 700 - $260 100 / an

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 0%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Intuitive

Intuitive

Site WebLinkedInTous les Emplois

5001 - 10000 employés

Fondée en 1995

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Intuitive est une entreprise reconnue pour ses technologies chirurgicales innovantes, notamment les systèmes chirurgicaux da Vinci, utilisés pour des interventions mini‑invasives. Forte de trois décennies de résultats éprouvés, Intuitive œuvre à faire progresser les soins de santé en proposant des parcours de formation technologique structurés et mesurables à l’intention des chirurgiens, des médecins et des équipes du bloc opératoire. Sa vision : améliorer les résultats pour les patients grâce à une prise en charge chirurgicale moins invasive. Intuitive propose également une plateforme de médias visuels dédiée à la collaboration et à l’apprentissage, le Da Vinci Hub, ainsi que la plateforme SimNow pour la formation chirurgicale. L’entreprise poursuit en continu ses efforts d’innovation afin d’explorer de nouvelles possibilités en matière de soins chirurgicaux.

Description

• Set statistical vision and direction for clinical studies from early feasibility through pivotal pre-market trials and post-market evidence generation • Independently develop statistical approaches for complex clinical protocols, including design selection, endpoints, estimands, hypothesis tests, power analyses, sample size, randomization, adaptive designs, and interim analyses • Serve as final internal statistical authority and unblinded sponsor statistician for DMCs/DSMBs • Set standards for Statistical Analysis Plans and mock Tables, Listings, and Figures; review and approve others' work • Direct clinical-trial data analysis, complex analytical problems, interim analyses, database lock, and unblinding • Manage a portfolio of 10 or more concurrent projects and allocate statistical effort across multiple functional areas • Represent Biostatistics in core-team and program-level forums; shape evidence-generation strategy, roadmaps, timelines, and stakeholder expectations • Influence senior leadership and translate statistical complexity into actionable clinical and business direction • Lead biostatistics meetings and set agendas • Write or edit methods, results, and interpretation sections for regulatory submissions, compliance documents, journals, and conferences • Conduct analyses of large clinical or administrative databases, systematic literature reviews, and meta-analyses • Contribute to peer-reviewed publications, conference presentations, and methodological research • Represent Intuitive Biostatistics with regulatory agencies, principal investigators, key opinion leaders, and external statisticians • Partner with Data Management on data quality, consistency, scalability, traceability, and CDISC-aligned SDTM/ADaM structures • Set department programming and analysis standards; develop SOPs and work instructions for standardization, validation, and quality control • Set training curricula, deliver methodology and programming training, and provide technical and career-development guidance • Oversee and direct external statistical vendors and CROs • Ensure compliance with applicable clinical research and regulatory standards

🎯 Exigences

• Master's (MS) or Ph.D. in Biostatistics or Statistics • Minimum 9 years of professional experience with an MS, or 6 years with a Ph.D. • Minimum 5 years of clinical trial experience • Minimum 5 years of medical device experience • Surgical and robotic-assisted device clinical research strongly preferred • Track record developing and applying innovative biostatistical methodology • Expertise across adaptive and group-sequential designs, Bayesian methods, historical or external controls, survival and longitudinal modeling, hierarchical models, multiplicity control, missing data and sensitivity analysis, and large real-world datasets • Mastery of R required; SAS and Python valued • Ability to set programming standards and write clean, functional, modular, well-tested code • Fluency in Git and version control in a GxP-validated environment • Experience applying frontier AI models to redesign biostatistics workflows, with specific verifiable examples and quantified gains • Ability to establish reliable, reproducible, compliant AI-assisted workflows with human-in-the-loop verification • Fully independent operation with substantial technical leadership scope • Established external scientific and regulatory reputation with sustained relationships • Excellent verbal and written communication, teamwork, and interpersonal skills • Strong scientific writing and editing skills, attention to detail, and scientific integrity • Compliance with GCP, ISO 14155, ICH E9, ICH E6, and 21 CFR Part 812 • Situationally relevant FDA guidance knowledge, including adaptive designs and Bayesian methods for medical device trials • Preference for candidates able to be onsite in Sunnyvale, California or willing to relocate • Candidates may be subject to U.S. export-control requirements, export licensing, or a Technology Control Plan • Qualified applicants must meet applicable work authorization and fair-chance requirements

🏖️ Avantages

• Remote work arrangement; employees come onsite when requested by the leader • Up to 10% travel • Potential vaccination requirements, including COVID-19 vaccination • Base pay, incentives, benefits, and equity as part of the compensation package • Equal employment opportunities and anti-discrimination protections

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