Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company committed to developing and
commercializing innovative medicines to meet the needs of patients living with rare and other diseases with high
unmet medical needs.
At Santhera, our people are the driving force behind our success. Our collective loyalty, courage, and resilience
set us apart and help us thrive through change as a collaborative team. We create a purposeful workplace where
your contribution matters, growth is fostered, and together we make a real impact for those living with rare
diseases and for each other.
Come and join our team to contribute to providing treatment options for patients with rare diseases that have a
severe impact on the lives of affected children and adults. You can make a difference as:
Senior Biostatistician
Location: Pratteln, Switzerland (Hybrid)
Scope of Work
The Senior Biostatistician provides statistical leadership across one or more products lifecycle, supporting
clinical development, regulatory submissions, safety surveillance, medical affairs ac-tivities, and market access
activities.
The Senior Biostatistician works closely with Data Management and serves as a key scientific partner to Clinical
Development, Clinical Operations, Regulatory Affairs, Drug Safety and Phar-macovigilance, Medical Affairs and
Market Access and external partners to ensure robust evi-dence generation supporting regulatory and
commercial objectives.
The role combines strategic statistical and collaborative leadership, with hands-on responsibili-ties. It is
responsible for the statistical design, analysis, interpretation, and reporting of clinical tri-als and observational
studies, while performing the statistical programming required for study analyses and reporting. The role requires
strong technical expertise, scientific rigor, strategic thinking, and the ability to communicate complex statistical
concepts to multidisciplinary teams.
Key Responsibilities, but are not limited to:
Scientific & Technical Excellence
- Lead statistical activities for Phase I-IV.
- Contribute to clinical development plans and integrated evidence-generation plans.
- Provide statistical input into study design, endpoint selection, estimand strategies, multiplicity control,
sample size determination, and analysis methodologies.
- Provides input into study protocols, develops Statistical Analysis Plans (SAPs) and statistical sections
of relevant clinical and regulatory documents, and publications.
