2025 - 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
:

• Lead the strategic application of advanced and adaptive clinical trial designs (e.g., Bayesian, seamless Phase I/II designs) to maximize learning and optimize decision-making in early-phase development
• 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
• Demonstrated success in the development, evaluation, and application of novel statistical methodologies to address complex challenges in clinical development
• Significant expertise in clinical trial design and analysis for Oncology studies, with a strong focus on early-phase (Phase I/II) development
• Proficiency in statistical programming using SAS or R, with substantial experience in applying these tools to complex clinical trial analysis
• 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:

If your application is selected, you'll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams, followed by a panel interview and reference checks. Communication is handled via Workable—check your spam folder for emails from
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Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters.

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