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**:

* 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.*

**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 *\*@outbound.workable.com*.

*Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters.*

* 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