Principal Statistician - Early Phase in Winit Germany GmbH, Bremen at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Statistician - Early Phase based in Germany.

As a Principal Statistician specializing in early-phase clinical development, you will provide strategic statistical expertise throughout the full lifecycle of clinical studies, from protocol development to clinical study reporting. You will act as a key scientific partner, supporting study design, statistical analysis, regulatory activities, and high-quality data-driven decision-making. Working with multidisciplinary global teams, you will contribute to innovative healthcare solutions while mentoring statisticians and ensuring excellence across project delivery. This role offers the opportunity to influence complex clinical programs, collaborate with experts across functions, and make a meaningful impact on the development of new therapies.

• Serve as a senior statistical expert supporting clinical studies across all phases of development, from protocol design through clinical study report (CSR) completion.
• Provide statistical leadership on assigned projects, including study design, analysis strategies, randomization approaches, and interpretation of clinical trial results.
• Develop, review, and oversee Statistical Analysis Plans (SAPs), including specifications and mock-up tables, listings, and figures.
• Support the creation and review of analysis datasets, statistical programming specifications, and clinical trial documentation.
• Partner with cross-functional teams including clinical, data management, programming, regulatory, and project management stakeholders to ensure successful study delivery.
• Conduct quality control reviews of statistical deliverables to ensure accuracy, consistency with analysis plans, and compliance with applicable standards.
• Mentor and support biostatistics colleagues by sharing expertise, providing training, and contributing to professional development initiatives.
• Lead complex studies, integrated analyses, regulatory submissions, and interactions with regulatory agencies when required.
• Support Data Safety Monitoring Board (DSMB) and Data Monitoring Committee (DMC) activities, including statistical input and review.
• Contribute to business development activities through proposal support, budgeting input, and participation in client discussions.

• Graduate degree in Biostatistics, Statistics, Mathematics, or a related quantitative discipline.
• Extensive experience in clinical trials, biostatistics, or a comparable research environment, with demonstrated ability to lead complex projects.
• Strong understanding of statistical methodology, clinical trial design, analysis techniques, and relevant regulatory guidelines such as ICH standards.
• Experience supporting the complete statistical lifecycle of clinical studies, including protocol development, SAP creation, analysis, and CSR preparation.
• Proficiency in R programming and experience applying statistical programming techniques in clinical research environments.
• Experience reviewing or supporting regulatory submissions is highly desirable.
• Strong ability to communicate complex statistical concepts clearly to technical and non-technical stakeholders.
• Excellent written and verbal communication skills in English.
• Ability to manage multiple priorities, meet deadlines, and work effectively in a global, remote environment.
• Experience mentoring colleagues or providing statistical guidance to junior team members is an advantage.

• Fully remote working opportunity from Europe with flexible work arrangements.
• Opportunity to contribute to meaningful clinical research programs that support the development of new therapies.
• Collaboration with international teams of scientific and healthcare experts.
• Career development opportunities through training, mentorship, and exposure to diverse therapeutic areas.
• Access to a global environment focused on innovation, knowledge sharing, and professional growth.
• Opportunity to work on complex clinical studies and gain experience across different stages of drug development.
• Inclusive workplace culture that values collaboration, diversity, and individual contributions.