Senior Clinical Trial Manager at ICON managing clinical trial responsibilities and fostering stakeholder relationships. Overseeing budgets, study oversight, and driving enrollment in trials.
About the role
- Senior Biostatistician managing statistical expertise for Arthrex's Research team in Munich. Overseeing study designs, compliance, and analytics to support medical device research.
Responsibilities
- Act as the statistical lead for the Arthrex Research team, shaping study design and evidence planning across cross-functional teams
- Serve as the primary statistical authority for Clinical Research, providing expert guidance with minimal oversight
- Design and guide impactful research—from defining endpoints and sample sizes to developing protocols and comprehensive Statistical Analysis Plans
- Drive advanced analytics and deliver submission-ready reports in full compliance with local and global standards (ICH, FDA, ISO, GCP, and MDR)
- Champion data integrity, collaborating with data management to optimize collection systems and ensure quality
- Conduct statistical analyses using R, SAS, Python or equivalent tools; apply appropriate statistical models including mixed models, categorical, Bayesian, and multivariate approaches as appropriate
- Translate insights into action, presenting results in reports, publications, and briefings, and making complex concepts clear for diverse stakeholders
- Mentor and guide junior or non-statistical personnel, acting as the statistical subject matter expert across the Research department
Requirements
- Master’s degree (or equivalent) in Biostatistics, Statistics, or a related field; PhD preferred
- Extensive experience in the medical device or pharmaceutical industry
- Proven proficiency in statistical programming (R, SAS, Python)
- Experience with regulatory statistical submissions and applicable standards (FDA, MDR, ISO, ICH, etc.)
- Experience with medical device clinical research (preferred)
- Experience with additional data sources (e.g., registries, real-world data, observational datasets) is a strong plus
- Collaborative mindset and ability to work effectively in cross-functional, global teams
- Strong written and verbal communication skills in both English and German.
Benefits
- Motivating and appreciative work environment
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Clinical Trial Manager overseeing site management and monitoring deliverables for clinical trials. Ensuring compliance and data integrity in a hybrid work environment based in Bucharest.
B(
Clinical Research Coordinator I managing patient recruitment for Gout Study at Boston Medical Center. Conducting assessments, enrolling participants, and ensuring data quality in a supportive environment.
Clinical Scientist responsible for clinical performance and product development for Ultrasound technologies at Philips. Collaborating with R&D and clinical leaders to meet strategic objectives.
Compliance Audit Manager conducting research billing audits and managing the Research Billing Compliance program at McKesson. Engage in key audits at oncology practices ensuring ethical and lawful practices.
Clinical Research Manager coordinating clinical studies from planning to publication for digital health solutions. Ensuring compliance, conducting analyses, and collaborating interdisciplinarily.
Clinical Scientist executing and supporting clinical trials at Oruka Therapeutics. Collaborating with teams to ensure high - quality data collection and analysis for chronic skin disease treatments.
Clinical Scientist assisting the Clinical Research Director in studies related to asthma and inflammatory diseases. Supporting clinical trial execution and document preparation at a biopharma company.
Head of CRO Channel Sales leading partnerships and direct sales for ProofPilot’s clinical trial solutions. Focused on developing high - impact partnerships within the clinical trial ecosystem.
Clinical Research Coordinator II at University of South Florida responsible for coordinating clinical research activities and ensuring participant data quality. Serving as main contact for sponsors and patients for specific research protocols.