T2025 Principal Biostatistician Oncology focus early phases contractor
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Job Location:
Lausanne - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 Debiopharms 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 plansyou 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 were 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 youll 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 Workablecheck your spam folder for emails from *@.
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 arent just values theyre 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
Required Experience:
Staff IC
Key Skills
- Hospital Experience
- Acute Care
- Basic Life Support
- ICU Experience
- Infusion Experience
- Triage
- TFS
- Conflict Management
- Nursing
- Critical Care Experience
- Epic
- Medication Administration
About Company
Debiopharm develops, manufactures, and invests in innovative therapies and technologies that respond to high unmet medical needs in oncology and bacterial infections. In addition to drug development and manufacturing, Debiopharm aims to provide strategic funding and guidance for compa ... View more
