Senior Statistical Programmer

Working as a Senior Statistical Programmer in our Lausanne, Paris, or Cambridge UK office, you will use your advanced SAS programming expertise and in-depth knowledge of industry-wide standards to lead and support clinical studies across all phases of development. 

Reporting to the Director of Biostatistics, you will work closely with a small group of Biostatistician-Programmers to lead and support key aspects of the programming effort, ensuring the successful delivery of data and reporting components for various projects.  

Responsibilities include, but are not limited to, the following:  

Advanced SAS Programming Expertise 

• Proficient in Base SAS, SAS/Macro, SAS/SQL; experience with SAS/Graph is a plus 

• Demonstrated ability to develop, maintain, and troubleshoot SAS macro libraries 

Strong Knowledge of CDISC Standards 

• Hands-on experience with the implementation of SDTM and ADaM datasets 

• Experience in Define-XML creation and CDISC validation tools such as Pinnacle 21 

Regulatory Reporting Experience 

• Direct involvement in generating outputs for periodic regulatory submissions (e.g., DSURs, PSURs, Annual Safety Reports) 

• Working knowledge of FDA and EMA submission requirements 

Lead and Validation Programming 

• Experience leading programming efforts for the creation and validation of SDTM and ADaM datasets and statistical outputs (tables, listings, figures) 

• Ability to conduct and document independent validation of programming deliverables 

Standardization of Outputs 

• Proven track record in building and maintaining a suite of standardized, reusable outputs and templates to support multiple studies 

Collaborative and Communication Skills 

• Comfortable working cross-functionally with statisticians, data managers, and clinical teams 

• Strong documentation practices and the ability to communicate technical concepts clearly 

Quality and Compliance Focus 

• Commitment to Good Programming Practices (GPP) and regulatory compliance 

• Strong attention to detail and thorough understanding of QC processes in a clinical trial settin

Requirements

• Bachelor’s or master's degree in Statistics, Computer Science, Engineering, or a related field 

• Minimum of 5 or more years of experience in clinical trial programming within the pharmaceutical, biotech, or CRO industry 

• Advanced knowledge and experience in: 

• SAS programming: experience in R is a major asset 

• CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices 

• Technical and regulatory requirements related to the role 

• Database set-up 

• Clinical drug development 

• Proficiency in English - conversational French would be a plus