Head of Biostatistics & Data Management

Head of Biostatistics & Data Management

Debiopharm Group

Lausanne, Switzerland

At Debiopharm, we are driven by a singular mission: to develop for patients. As the Head of Biostatistics & Data Management, you will play a pivotal role in this mission by leading a dedicated team of highly skilled professionals to provide cutting-edge expertise to all our clinical programs. In this pivotal role, you will design and execute the innovative data strategy that underpins our clinical development pipeline, ensuring the highest standards of scientific rigor and regulatory compliance across all trials and study phases, fundamental to our global product registration efforts.

Your Mission

Strategic Leadership and Team Development:

• Lead, align, and motivate the Biostatistics and Data Management organization to ensure unwavering commitment and engagement.
• Mentor a growing team of statisticians, data managers, and statistical programmers, and oversee collaborations with CROs and external vendors to deliver world-class analytics and insights.
• Drive organizational and talent development, along with resource planning, to secure the achievement of both short and long-term goals.

Statistical and Methodological Oversight:

• Supervise and provide guidance on statistical design methodology across programs, including input to clinical development plans, trial protocols, SAPs, and CSRs, ensuring they comply with regulatory requirements.
• Lead the development and implementation of innovative statistical models and methods, keeping the team current with state-of-the-art practices and global regulatory guidance.
• Personally perform the duties of a project statistician when required, providing input on study design, endpoints, sample size calculation, and reviewing Case Report Forms.

Regulatory and Compliance Command:

• Take responsibility for the statistical components of Clinical Trial Reports for all regulatory submissions.
• Supervise and directly contribute to regulatory strategy and submission documents such as Briefing Books, NDA/CTD, and official responses to regulatory agencies.
• Define and ensure the compliance of all SOPs, standards, and templates with FDA, EMA, ICH, and CDISC guidelines.

Cross-Functional Collaboration and Communication:

• Partner cross‑functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Translational Medicine to shape study protocols, drive forward-thinking statistical contribution, and guarantee data integrity through advanced systems and processes.
• Supervise the preparation of oral and written reports to effectively communicate the results of clinical trials.
• Work hand-in-hand with the Digital & IT department to strategically evolve and maintain our digital platforms and tools that align with state-of-the-art industry trends.

More than a checklist of skills, we’re looking for someone who shares our commitment to science with purpose.

Requirements

Your profile:

• A Ph.D. in Statistics, Biostatistics, Mathematics, or a related field.
• A minimum of 12 years of experience in the biotech or pharmaceutical industry, with at least 8 years leading Biostatistics, Statistical Programming, and Clinical Data Management functions.
• Proven expertise in clinical and pharmaceutical industry experience in planning and conducting clinical trials, preferably in early phase clinical development oncology studies within a pharmaceutical industry setting.
• Demonstrated expertise in statistical design and planning, data analysis, and reporting of clinical trial data.
• Extensive knowledge of GCP, ICH guidelines, FDA and EMA regulations.
• Proven experience with eCTD NDA submissions.
• Solid, hands-on knowledge of relevant statistical software like R, SAS is necessary.
• Strong appetite for Innovation, Digitalization and AI with hands-on experience an asset.
• Exceptional leadership, communication, and interpersonal skills, with the ability to thrive in a cross-functional, matrix environment.
• High degree of motivation and a results-oriented mindset are key, with the ability to work in a quickly changing environment.
• Excellent verbal and written communication skills in English.