Associate Director, Biostatistics

Pharmacie de la Place du Cirque SA seeks an Associate Director of Biostatistics in St. Gallen to lead statistical strategy for clinical trials and regulatory submissions.

The company is looking for a senior biostatistics leader to define and execute statistical strategies for clinical development programs. This role involves guiding study designs, ensuring methodological rigor, and representing the department in regulatory interactions to support drug development goals.

Responsibilities

• Establish statistical strategies and apply appropriate methodologies to study designs and data analysis for clinical trials and regulatory filings.
• Contribute to clinical development plans and collaborate with cross-functional teams during governance reviews.
• Lead statistical planning and execution as a member of the Study Executive Team and Clinical Development Team.
• Provide thought partnership on innovative study designs, including Go/No-Go criteria and probability of success calculations.
• Oversee project-wide analysis planning to ensure timely and high-quality delivery of interim and final results.
• Represent the biostatistics function in communications with regulatory bodies such as the FDA, EMA, and PMDA.
• Interpret analysis results and ensure accuracy in study reports and regulatory documents.
• Manage outsourcing operations or collaborate with internal statistical programmers to ensure deliverable quality and timeliness.
• Support or lead improvement initiatives within the department and the broader pharmaceutical industry.
• Prepare abstracts, posters, and presentations to communicate clinical program results to internal and external stakeholders.

Requirements

• PhD or MS in Biostatistics, Statistics, or a related field.
• PhD with 8 years of experience or MS with 11 years of experience in drug development.
• Proven experience providing statistical leadership at the compound or indication level.
• Demonstrated expertise in facilitating and optimizing clinical development strategies.
• Solid experience in applying advanced statistical methodologies.
• Experience in leading roles for regulatory submissions.
• Strong interpersonal and communication skills in English.
• Working knowledge of SAS and/or R.
• Expertise in a range of statistical methodologies.
• Knowledge of CDISC, statistical programming, and data standards.

Nice to have

• Experience interacting with major regulatory authorities.
• Experience managing CROs or working within a CRO environment.
• A track record of innovation.

What the company offers

• Information on CSL benefits and well-being support.

About the company

CSL Vifor is a global partner for pharmaceuticals and innovative therapies in iron deficiency and nephrology, specializing in strategic partnering, in-licensing, and manufacturing. Headquartered in St. Gallen, Switzerland, it includes the joint venture Vifor Fresenius Medical Care Renal Pharma. Its parent company, CSL, is based in Melbourne, Australia, employs 32,000 people, and delivers therapies to over 100 countries.

• Inclusion and belonging are core to the company's mission.
• The culture celebrates differences and fosters curiosity and empathy.
• The company aims to sustain a diverse workforce to drive future growth.