Tubulis is looking to accelerate drug discovery, optimize clinical trials, regulatory submissions, and development processes using AI and machine learning (ML) by establishing a strategic leadership role for their Data Science function.
Requirements
- PhD or equivalent in Computational Biology, Bioinformatics, Computer Science, Biostatistics, or a related scientific/quantitative field.
- Extensive experience (10+ years) in biostatistics and data management within a pharmaceutical, biotech and academic environment.
- Deep knowledge of scientific decision processes integral to research and regulatory submissions.
- Experience in leading preclinical and clinical research projects and familiarity with regulatory requirements and clinical data lifecycle.
- Must have experience working within Oncology clinical trials.
- Experience supporting pivotal Phase III programs and proven statistical expertise in statistical planning, study design, data.
- Ability to develop vision and strategy for biostatistics and data science functions.
Responsibilities
- Lead, oversee and execute biostatistics, statistical programming, data management, and data science activities for preclinical and clinical studies across the global portfolio.
- Develop and communicate the vision and mission of the biostatistics and data sciences platform, driving strategic plans to achieve organizational goals.
- Partner with leaders across biology, chemistry, clinical development, and IT to integrate data-driven insights into the end-to-end drug development lifecycle.
- Oversee the creation of predictive models for clinical outcomes, efficacy, safety profiles, and asset prioritization using multi-modal data.
- Ensure appropriate design, collection, management, statistical analysis, and reporting of clinical study data, supporting the entire study data lifecycle.
- Establish robust data management frameworks ensuring data quality, integrity, and security while adhering to global regulatory standards like GxP, HIPAA, and FDA 21 CFR Part 11.
- Drive standardization, harmonization, and process optimization to increase productivity, quality, and reduce cycle times and costs.
Other
- Proven leadership experience managing and building diverse and high-performing global teams.
- Ability to foster innovation and continuous improvement in biostatistics and data management process.
- Proactive and independent thinker and strong team player.
- Strong organizational, communication, and personnel management skills.
- Entrepreneurial and problem-solving mindset.
