Sr. Statistical Programmer - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
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.
- 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.
Source : Katalyst Healthcares & Life Sciences
