Address
Form of work Responsibilities :
- Program analysis datasets, statistical tables, figures, and listings.
- Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation.
- Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
- Ensure quality of project programming deliverables.
- Provide input on programming methodologies to support the clinical development process.
Requirements:
- Bachelor's degree in Statistics, Computer Science, Mathematics, or related technical discipline. An equivalent combination of education and applicable job experience may be considered.
- Minimum of 4 years' experience in clinical research, ideally as a SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
- Technical knowledge and experience with SDTM, ADaM, and Define.XML.
- Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
- Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Familiarity or experience with R Software is a plus.
- Proven experience with UNIX and Windows operating systems.
- Ability to effectively communicate and perform in a high demand and dynamic working environment.
