Staff Biostatistician

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

📋 Description

• Establish the statistical vision and strategic direction for clinical studies, ranging from early feasibility investigations to pivotal pre-market trials and post-market evidence generation.

• Formulate statistical methodologies 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 final internal statistical authority for assigned studies and provide advisory support at both program and platform levels.

• Serve as the unblinded sponsor statistician for Data Monitoring Committees and Data Safety Monitoring Boards (DSMBs).

• Establish standards, templates, and pre-specification expectations for Statistical Analysis Plans (SAPs) and mock Tables, Listings, and Figures (TLFs); review and approve deliverables.

• Oversee clinical trial data analysis and personally manage complex or novel analytical challenges.

• Direct interim analyses, database locking, and unblinding activities.

• Manage a portfolio of 10 or more concurrent projects, allocating statistical resources effectively.

• Represent the Biostatistics team in core-team and program-level forums, influencing evidence-generation strategies and execution roadmaps.

• Engage with senior leadership to translate statistical complexities into actionable clinical and business strategies.

• Lead biostatistics meetings and establish meeting agendas.

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

• Lead research initiatives involving large clinical or administrative databases, systematic reviews, and meta-analyses.

• Contribute to peer-reviewed publications, conference presentations, and methodological advancements.

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

• Collaborate on data quality strategies and define CDISC-aligned SDTM and ADaM structures alongside analysis-ready datasets.

• Establish programming and analysis standards; create Standard Operating Procedures (SOPs) and work instructions for standardization, validation, and quality control.

• Develop training curricula and deliver methodology and programming training sessions.

• Provide technical leadership and mentorship to junior statisticians.

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

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

⛳️ Requirements

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

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

• Minimum of 5 years in clinical trial settings.

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

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

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

• Proficiency in various 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 handling large real-world datasets.

• Required mastery of R; familiarity with SAS and Python is also valued.

• Capability to establish programming standards, write clean modular tested code, and lead code review and validation processes.

• Proficient in Git and version control within a GxP validated setting.

• Demonstrated experience in applying advanced AI models to optimize biostatistical workflows, with specific verifiable examples and measurable benefits.

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

• Capability to operate fully independently with a significant scope for technical leadership.

• Established external scientific and regulatory credibility with maintained relationships.

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

• Strong scientific writing and editing abilities, with attention to detail and a commitment to scientific integrity.

• Adherence to GCP, ISO 14155, ICH E9, ICH E6, and 21 CFR Part 812.

• Preference for candidates who do not currently reside, or intend to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

• U.S. export-control regulations may apply to individuals from embargoed or sanctioned countries.

🏝️ Benefits

• Remote work flexibility; employees are expected to come onsite only when requested by their leader.

• Up to 10% travel required.

• Potential vaccination coverage or requirements for specific diseases, including COVID-19.

• Competitive compensation packages that include base salary, incentives, benefits, and equity options.

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