Job Description
This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams
Essential 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:
- Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline.
- 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.
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