|Summary of Job Responsibilities:
As member of the Biostatistics and Data Management (BDM) department, and reporting to the Global Head of Clinical Data Management or to the local manager (Director or Associate Director of Data Management), the main responsibilities of the Clinical Programmer will be to:
- Provide for clinical project support across multiple therapeutic areas.
- Work closely with data management to ensure data quality.
- Contribute to EDC programming and reporting activities.
- Work as part of a clinical team developing SAS templates and utilities for data cleaning and reporting;
- Able to communicate with all levels of internal team members and sponsors.
- Perform quality control measures on deliverables.
- Understand and support clinical data management needs.
- Lead clinical programming activities on BDM projects:
- Programming (or write validation programs for) and document SDTM deliverables for SDTM Migration;
- Developing program specifications and design documents;
- being accountable for the quality, traceability, reproducibility and timeliness of programming deliverables,
- being accountable for overall client satisfaction with these deliverables,
- efficiently communicating with internal and external clients
- Ensure the clinical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
- Clinical study reporting, e.g. ICH E3
- Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11
- Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM standards
- Understand and follow all BDM SOPs as well as any other relevant SOPs.
- Keep abreast of current and new programming techniques and other applicable technical advancements while assisting in their implementation
Qualifications and Experience:
A BA or BS degree or equivalent in computer science, mathematics, statistical or life sciences field. Previous clinical data management or clinical programming experience may substitute for the post-secondary educational requirements.
- Minimum Work Requirements:
- A minimum of 6 years hands on relevant experience in the biotechnology or pharmaceutical industry in clinical development.
- Excellent knowledge of SAS SAS BASE, MACRO.
- Good Knowledge of CDISC CDASH and SDTM guidelines.
- Experience as a lead programmer with and ability to contribute to implementing CDISC models.
- Skilled in use of computer technology, including clinical trial databases and applications (e.g., Merge eClinicalOS, Medidata Rave) and ability to learn new applications.
- Good Overall understanding of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.
- Fluent in English (French and/or German is a plus)
- Ability to work effectively in international teams, excellent team player
- Ability to work independently is required