Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – email@example.com
- Independently develop/validate programs that generate SDTM and analysis datasets based on ADaM specifications.
- Prepare/QC ADaM datasets documentation: Define.xml, Reviewer’s Guide and analysis metadata report.
- Independently develop/validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan (SAP)
- Perform quality control on final reports.
- Provide QC and validation reports.
- Support development of technical programming specifications for ADaM standards
- Communicate with programming and statistics leads, data managers and other team members.
- Provide project progress updates of programming activities.
- BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences
- 10+ years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
Required Skills Include:
- Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Stat
- Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio is a plus.
- Experience with all clinical phases I, II, III and IV of trials is desirable.
- Good understanding of standards specific to clinical trials such as CDISC, SDTM, ADaM, MedDRA, WHODRUG
- Strong problem-solving skills
- Good organizational and time management skills
- Excellent communication skills and capability of communicating technical concepts.
- Excellent organizational skills with demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.