A leading international pharmaceutical company has an outstanding opportunity for a permanent Principal Statistical Programmer to be based in there head office in Switzerland.
KEY RESPONSIBILITIES:
Responsible for all project level programming aspects (analysis datasets, pooled datasets, listings and tables) for drug project.
- Manage the programming activities for a global project following internal project management guidelines including resource planning.
- Act as Program Programmer for assigned projects and take a programming leadership role on the B&SR project team.
- Maintain efficient interfaces with internal and external customers with advice from SR management.
- Develop and comply with project / study standards and specifications following internal and regulatory guidelines.
- Oversee programming style, quality of SR contributions and compliance with timelines.
- Provide SR input and lead sections of Full Development and Submission Working Groups.
- Ensure that documents and specifications are consistent and comply with company standards by providing input into study protocol, CRF and data structures.
- Program, according to specifications, analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for SCS and SCE. Ensure quality control and quality audit of deliverables.
- Maintain records for all assigned projects and archive trial / project analysis and associated documentation.
- Participate in the selection of CROs, as required, and supervise SR project activities for CROs.
- Train staff on trial and project level activities and internal processes.
- Participate in or lead non-clinical project activities. for SCS and SCE with high quality and within milestones.
Minimum requirements
- BA/BS or equivalent experience in mathematics, statistics, computer science, life sciences or related field.
- Languages: Fluent English (oral and written)
- Expert knowledge of / experience with SAS software
- Good understanding of global clinical trial practices, procedures, methodologies
- Good understanding of regulatory requirements relevant to SR (e.g. GCP, ICH)
- Experience in providing recommendations for maintenance or development of SR global policies, procedures and clinical data presentation standards
- Intermediate knowledge of office tools
- Solid experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry
This job was posted 30+ days ago, and has expired.
