Lead Statistical Programming

Biostats & Data ManagementLausanne, Vaud, SwitzerlandFull time

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Description

Debiopharm™ is a Swiss-headquartered global biopharmaceutical group active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.

For our Biostatistics and Data Management Department (around 12 people), we are seeking a highly motivated, and collaborative

Lead Statistical Programming

The Manager Statistical Programming provides functional expertise and leadership to Statistical Programming and Biostatistics teams while delivering programming expertise to clinical projects and studies. He/she is primarily responsible for defining and implementing programming standards and developing technical solutions for integrating, analysing and reporting clinical data. He/she manages a team of statistical programmers and is accountable for the quality and timelines of all statistical programming deliverables for clinical programs and studies, including studies for which statistical programming activities are outsourced to CRO partners. He/she works in close collaboration with Biostatistics, Data Management, Data Science and Clinical Development.

Your Main responsibilities:

• Ensure quality of Statistical Programming deliverables by consistently applying analysis and reporting standards and driving compliance with SOPs and regulatory requirements.


• Manage a team of statistical programmers and the resource planning for their assigned studies.


• Oversee the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries.


• Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions.


• Provide technical guidance to vendors around project standards, programming conventions/specifications and programming practices to ensure efficient and integrated project reporting strategies.


• Provide mentoring and support to statistical programmers and biostatisticians.


• Provide input/leads internal process improvement.


• Ensure adherence to GCP, regulatory guidelines, standard processes, and SOPs.

Your profile:

• MSc in statistics, biostatistics, mathematics, computer science


• Minimum of 7 years statistical programming experience within pharmaceutical clinical development.


• Extensive knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements.


• Extensive knowledge of SAS software and general computing technics.


• Ability to work successfully within cross-functional teams, developing and maintaining successful partnerships.


• Demonstrated ability to adapt quickly to changing needs within the organization.


• Communicates proactively and effectively, excellent verbal and written communications skills.

Debiopharm can offer you:

• An international and highly dynamic environment.


• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.


• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

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