Lead Biostatistician

This is a fully remote position, open to applicants in Germany.

📋 Description

• Establish a statistical vision and direction for clinical studies starting from early feasibility stages to pivotal pre-market trials and post-market evidence generation.

• Independently create statistical strategies for intricate clinical protocols, encompassing design selection, endpoints, estimands, hypothesis testing, power analyses, sample size determination, randomization, adaptive designs, and interim analyses.

• Act as the definitive internal statistical authority and unblinded sponsor statistician for Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs).

• Set benchmarks for Statistical Analysis Plans and mock Tables, Listings, and Figures; review and authorize colleagues' work.

• Oversee clinical trial data analysis, tackle complex analytical issues, manage interim analyses, database locking, and unblinding processes.

• Manage a portfolio of 10 or more simultaneous projects and distribute statistical efforts across various functional areas.

• Represent Biostatistics in core-team and program-level discussions; influence evidence-generation strategies, timelines, and stakeholder expectations.

• Impact senior leadership by translating statistical complexities into actionable clinical and business directives.

• Lead biostatistics meetings and establish agendas.

• Author or revise methods, results, and interpretation sections for regulatory submissions, compliance documents, journals, and conferences.

• Perform analyses on extensive clinical or administrative databases, conduct systematic literature reviews, and execute meta-analyses.

• Contribute to peer-reviewed articles, conference presentations, and methodological research.

• Represent Intuitive Biostatistics in dealings with regulatory agencies, principal investigators, key opinion leaders, and external statisticians.

• Collaborate with Data Management to ensure data quality, consistency, scalability, traceability, and adherence to CDISC-aligned SDTM/ADaM structures.

• Establish programming and analysis standards within the department; develop Standard Operating Procedures (SOPs) and work instructions for standardization, validation, and quality assurance.

• Create training programs, deliver methodology and programming training, and offer technical and career development support.

• Supervise and direct external statistical vendors and Contract Research Organizations (CROs).

• Ensure compliance with relevant clinical research and regulatory standards.

⛳️ Requirements

• Master's (MS) or Ph.D. in Biostatistics or Statistics.

• At least 9 years of professional experience with an MS, or 6 years with a Ph.D.

• Minimum of 5 years of experience in clinical trials.

• At least 5 years of experience in the medical device field.

• Preference for experience in surgical and robotic-assisted device clinical research.

• Proven track record in developing and implementing innovative biostatistical methodologies.

• Expertise in 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.

• Proficiency in R is required; experience with SAS and Python is also valued.

• Ability to establish programming standards and produce clean, functional, modular, and well-tested code.

• Familiarity with Git and version control in a GxP-validated environment.

• Experience in applying advanced AI models to revamp biostatistics workflows, with specific verifiable examples and quantified improvements.

• Capability to create reliable, reproducible, and compliant AI-assisted workflows with human-in-the-loop verification.

• Ability to operate independently with significant technical leadership responsibilities.

• Established reputation in the external scientific and regulatory community, along with sustained relationships.

• Exceptional verbal and written communication skills, teamwork abilities, and interpersonal skills.

• Strong scientific writing and editing proficiency, meticulous attention to detail, and scientific integrity.

• Compliance with GCP, ISO 14155, ICH E9, ICH E6, and 21 CFR Part 812.

• Knowledge of relevant FDA guidelines, including adaptive designs and Bayesian methods for medical device trials.

• Preference for candidates who can be onsite in Sunnyvale, California, or are willing to relocate.

• Candidates may be subject to U.S. export-control regulations, export licensing, or a Technology Control Plan.

• Qualified applicants must fulfill applicable work authorization and fair-chance requirements.

🏝️ Benefits

• Flexibility to work remotely, with employees coming onsite as requested by leadership.

• Travel requirements of up to 10%.

• Potential vaccination mandates, including COVID-19 vaccination.

• Competitive base salary, incentives, benefits, and equity as part of the overall compensation package.

• Commitment to equal employment opportunities and anti-discrimination protections.