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T2512 - Principal Biostatistician - Oncology Focus Early Phases (Contractor 12 Months)
vor 4 Wochen
Description
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**:
**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
