P2501 - Clinical Development Principal Biostatistician

Debiopharm is dedicated to advancing patient care through innovative therapies in oncology and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we employ a unique “development only” business model focused on developing high-impact therapies that can make a significant difference in patient lives. Join us at Debiopharm to engage in groundbreaking research and contribute to our mission of improving health outcomes globally.

For our Biostatistics and Data Management organization based at our Headquarters in Lausanne, we are looking for a

Clinical Development Principal Biostatistician

As the Clinical Development Principal Biostatistician, you will lead the biostatistics strategy for clinical studies and ensure the integrity of statistical analyses conducted on clinical data. You will collaborate with cross-functional teams to drive biostatistical methodologies and contribute towards the successful development of Debiopharm’s innovative medicine.

Your responsibilities will be but not limited to:

• Develop and oversee the biostatistical plan for clinical studies across all phases of development.
• Review and approve statistical analysis plans (SAPs) and ensure appropriate statistical methodologies are applied.
• Collaborate with clinical teams to define clinical study design, endpoint definitions, and analysis strategies.
• Lead the statistical programming activities and ensure timely delivery of statistical outputs including tables, figures, and listings (TFLs).
• Communicate statistical findings effectively to cross-functional teams and stakeholders.
• Develop and implement best practices and standard operating procedures for biostatistics.
• Ensure compliance with regulatory requirements and industry guidelines.

• Master’s degree or PhD in Biostatistics, Statistics, Mathematics, or a related field.
• At least 6-8 years of experience in biostatistics within the pharmaceutical or biotechnology industry.
• Proficient in statistical programming using SAS or R, with substantial experience in clinical trial analysis.
• Strong knowledge of regulatory guidelines, including ICH, GCP, and FDA regulations.
• Experience in clinical trial design and analysis for Oncology and/or Infectious Disease studies is a significant asset.
• Excellent analytical, problem-solving skills, and attention to detail.
• Strong communication skills in English (oral and written), with the ability to convey complex statistical concepts to non-statisticians.
• A proactive team leader with a proven record of delivering results in a fast-paced environment.

Debiopharm can offer you

• International, highly dynamic environment with a long term vision.
• Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
• Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
• Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
• Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.