Lead Statistical Programming
A global swiss pharmaceutical organisation is looking for a Manager in Statistical Programming to provide functional expertise and leadership to clinical projects and studies. The selected candidate will be responsible for establishing programming standards.
- 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.
Skills and Requirements
- 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.
- 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.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.