Responsibilities:
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.
Requirements:
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.
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 demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.
BruntWork
Mawave
Softgic
