Responsibilities: Provide hands-on Statistical Programming expertise for client's early phase translation medicine group. Responsible for creating ADaM safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter), and POPPK (NONMEM) datasets, PK non-compartmental (NCA) tables, figures, and listings (TFLs). Experience with Phase I studies, exposure response analysis, cross over design, and supported pooling of PK parameters required. Strong SAS technical skills and in-depth CDISC knowledge. Good knowledge regulatory requirements for submissions. Requirements: Education/Experience: Bachelor's Degree in Statistics, Computer Sciences, Bioinformatics, or related field, and 10 or more years of relevant experience Strong, recent experience working on Phase 1 studies specifically with PKPD data and having created ADPP and ADPC datasets Hands-on experience creating NONMEM datasets strongly preferred but will consider candidates who have exposure/knowledge of the process and has worked in-depth with PKPD/Phase 1 studies. Project/Study lead experience strongly preferred but not required. J-18808-Ljbffr