Staff Biostatistician

Job not on LinkedIn

🔥 7 minutes ago

🇩🇪 Germany – Remote

💵 $162.7k - $260.1k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 0%

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Intuitive

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1995

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Intuitive is a company known for its innovative surgical technologies, including the da Vinci Surgical Systems which are used for minimally invasive procedures. With three decades of demonstrated performance, Intuitive focuses on advancing healthcare by providing structured and measurable technology training pathways for surgeons, physicians, and OR care teams. Their vision is to improve patient outcomes through less invasive surgical care. Intuitive also offers a visual media platform for collaboration and learning, known as the Da Vinci Hub, and the Simnow platform for surgical training. The company is involved in ongoing innovation to explore new possibilities in surgical care.

📋 Description

• Set the statistical vision and direction for clinical studies from early feasibility through pivotal pre-market trials and post-market evidence generation • 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 for owned studies and advise at program and platform levels • Serve as unblinded sponsor statistician for Data Monitoring Committees and DSMBs • Set standards, templates, and pre-specification expectations for SAPs and mock TLFs; review and approve deliverables • Direct clinical-trial data analysis and personally own complex or novel analytical problems • Direct interim analyses, database lock, and unblinding activities • Manage a portfolio of 10 or more concurrent projects and allocate statistical effort • Represent Biostatistics in core-team and program-level forums, shaping evidence-generation strategy and execution roadmaps • 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 • Lead research involving large clinical or administrative databases, systematic reviews, and meta-analyses • Contribute through peer-reviewed publications, conference presentations, and methodological work • Represent Intuitive Biostatistics with regulatory agencies, principal investigators, key opinion leaders, and external statisticians • Co-strategize data quality and specify CDISC-aligned SDTM and ADaM structures and analysis-ready datasets • Set programming and analysis standards; develop SOPs and work instructions for standardization, validation, and quality control • Set training curricula and deliver methodology and programming training • Provide technical leadership and career-development guidance to junior statisticians • Oversee external statistical vendors and CROs • Ensure adherence to GCP, ISO 14155, ICH E9, ICH E6, and 21 CFR Part 812

🎯 Requirements

• Master's (MS) or Ph.D. in Biostatistics or Statistics • Minimum 9 years of 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 several statistical methods, including 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 additionally valued • Ability to set programming standards, write clean modular tested code, and lead code review and validation practices • Fluency in Git and version control in a GxP validated environment • Proven experience applying frontier AI models to re-engineer biostatistical 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 and 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 • Preference for candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee • U.S. export-control requirements may apply to nationals of embargoed or sanctioned countries

🏖️ Benefits

• Remote work; employees come onsite when requested by the leader • Up to 10% travel • Potential vaccination coverage/requirements for certain diseases, including COVID-19 • Market-competitive compensation packages including base pay, incentives, benefits, and equity • Equal employment opportunity and anti-discrimination protections