T2025 - Principal Biostatistician - Oncology Focus Early Phases - Contractor

We are currently looking for a motivated and collaborative professional to join our Data Management and Biostatistical department based at our Headquarters in Lausanne, Switzerland as

**Principal Biostatistician - Oncology focus early phases (Contractor 12 months)**

As the Principal Biostatistician focused on innovative programs, you will serve as the statistical architect for complex clinical studies, driving methodologies that accelerate the development of Debiopharm’s novel medicines. This is a high-impact, program-level role where your statistical leadership directly shapes key development decisions, particularly within our early-phase Oncology pipeline.

You will not just execute plans—you will define the strategy, introducing cutting-edge statistical approaches to maximize the efficiency and success of our most promising compounds.

**Your Mission.**

**Pioneer Innovative Designs**:

- Program-Level Strategy: Serve as the lead biostatistician for assigned development programs, defining the integrated statistical strategy across multiple studies and phases to ensure coherence and regulatory success.
- Drive Methodology: Review and approve Statistical Analysis Plans (SAPs), ensuring the implementation of the most appropriate and rigorous statistical methodologies to address complex endpoints and research questions.

**Cross-Functional Collaboration & Execution**
- Design Partnership: Collaborate closely with Clinical Development, Regulatory Affairs, and Data Management to define clinical study design, endpoint definitions, and analysis strategies that align with the Target Product Profile (TPP)
- Statistical Oversight: Oversee all statistical programming activities, ensuring the timely, high-quality, and compliant delivery of statistical outputs (TFLs) for clinical study reports, regulatory submissions, and internal decision-making.
- Communication & Influence: Effectively communicate complex statistical findings and design rationales to cross-functional teams, senior management, and external stakeholders, translating methodology into clear clinical and business implications.

**Compliance & Best Practices**
- Develop, implement, and champion best practices and Standard Operating Procedures (SOPs) for the biostatistics function.
- Ensure strict compliance with all global regulatory requirements and industry guidelines, including ICH, GCP, and FDA regulations.
- More than a checklist of skills, we’re looking for someone who shares our commitment to science with purpose._

**Requirements**:
**Your profile**
- PhD in Biostatistics, Statistics, Mathematics highly preferred
- At least 8+ years of experience in biostatistics within the pharmaceutical or biotechnology industry, with a substantial portion of this experience gained while performing program-level statistical leadership.
- Proven experience as the lead biostatistician overseeing the end-to-end statistical strategy for an entire development program (e.g., all studies for one molecule/indication), beyond just single-study execution.
- Significant expertise in clinical trial design and analysis for Oncology studies, with a strong focus on early-phase (Phase I/II) development.
- You are proactive, results-oriented with a proven ability to manage multiple projects and deliver results in a fast-paced, innovative environment.
- Excellent communication skills in English

**What to Expect in the Recruitment Process**:
**Benefits**
- Being part of a company where innovation, collaboration, and impact aren’t just values — they’re how we work every day
- Partner with teams across disciplines, at the forefront of oncology and anti-infective development
- An inclusive and respectful workplace — proud to be Equal-Pay certified
- Grow in a culture that values people, purpose, and performance
- A chance to grow, share, and shape the future of healthcare