P2608 - Head of Biostatistics & Data Management

Debiopharm seeks a Head of Biostatistics & Data Management in Lausanne, CH, to lead its biostatistics and data management team, drive innovative data strategies, and support clinical development for cancer and infectious disease treatments. The role requires a Ph.D. in Statistics or related field and extensive industry experience.

This role is central to Debiopharm’s mission of developing treatments for cancer and infectious diseases. It involves shaping an innovative data strategy for the clinical development pipeline, ensuring statistical rigor and regulatory compliance across all stages of drug development.

Responsibilities

• Lead, align, and inspire the Biostatistics and Data Management team.
• Mentor statisticians, data managers, and statistical programmers as the team grows.
• Oversee talent development, organizational growth, and resource planning.
• Guide statistical design methodology across clinical programs.
• Lead the creation and application of advanced statistical models and methods.
• Step in as a project statistician when needed.
• Own the statistical content in Clinical Trial Reports for regulatory submissions.
• Supervise and contribute to regulatory documents including Briefing Books, NDA/CTD, and responses to agencies.
• Ensure all SOPs, standards, and templates comply with FDA, EMA, ICH, and CDISC guidelines.
• Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, and Translational Medicine teams.
• Oversee the preparation of reports to present clinical trial outcomes.
• Work with Digital & IT to maintain and improve digital platforms and tools.

Requirements

• Ph.D. in Statistics, Biostatistics, Mathematics, or a related field.
• Minimum 12 years in biotech or pharmaceutical industry, including at least 8 years leading biostatistics, statistical programming, and clinical data management.
• Proven experience in planning and running clinical trials, especially early-phase oncology studies in pharma.
• Strong background in statistical design, data analysis, and clinical trial reporting.
• Deep understanding of GCP, ICH, FDA, and EMA regulations.
• Experience with eCTD NDA submissions.
• Practical, hands-on proficiency in statistical software such as R and SAS.
• Excellent leadership, communication, and interpersonal abilities, especially in cross-functional, matrix environments.
• Highly motivated, results-driven, and adaptable to fast-changing priorities.
• Superior verbal and written communication skills in English.

Nice to have

• Interest in innovation, digitalization, and AI, with practical experience in these areas.

What the company offers

• Opportunity to work in a company where innovation, collaboration, and impact are central to daily operations.
• Collaborate with multidisciplinary teams at the forefront of oncology and anti-infective drug development.
• Inclusive and respectful workplace environment — certified Equal-Pay.
• Culture that values people, purpose, and performance.
• Chance to grow, contribute, and shape the future of healthcare.

About the company

Debiopharm is a privately-owned Swiss company focused on science and patient impact. It follows a unique 'development only' model to accelerate therapy delivery. The company is driven by a mission to improve lives affected by cancer and infectious diseases, and values innovation, collaboration, and impact in its daily operations. It is proud to be Equal-Pay certified.

• Mission-driven focus on improving lives affected by cancer and infectious diseases.
• Privately-owned Swiss company committed to science and patient impact.
• Unique 'development only' model to bring therapies to patients faster.
• Culture of innovation, collaboration, and impact in daily work.
• Equal-Pay certified, promoting inclusive and respectful workplace.