Manager of Statistical Programming – Switzerland
Josh Zarembski is looking to speak with Senior Statistical programmers interested in joining a medium-sized award-winning biotech based in Switzerland. This organisation has previously outsourced all their programming to CRO’s and after restructuring now need the expertise to develop the department.
Reporting directly into the Head of Biometrics, You will be responsible for the structuring and set up of the in-house duties, the future expansion of the team and the oversight of existing CRO’s.
This client can offer
- An international environment with long-term career progression.
- The opportunity to work on some of the most advanced scientific developments within the industry, today.
- The ability to think creatively, innovatively, and out-of-the-box which is fundamental for their current success.
- 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.
- 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.