Senior Scientists, Statistical Programming

Merck Sharpe & Dohme Corp   Princeton, NJ   Full-time     Science
Posted on October 18, 2020

Senior Scientists, Statistical Programming Merck Sharp & Dohme Corp., a wholly-owned subsidiary of Merck & Co. Inc., is looking for Senior Scientists, Statistical Programming (multiple) for its Rahway, NJ location to support statistical programming activities for late stage drug/vaccine clinical development projects.

Must have MS in Statistics/Biostatistics or closely related field & 3 years SAS statistical programming experience in a clinical trial environment. Will also accept BS & 5 years experience.

Experience must include: developing analysis & reporting statistical programming deliverables (datasets, statistical analyses, report tables & graphics) using global & TA standards & according to quality, compliance & timeliness requirements; SAS & clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; using statistical analysis methods & clinical data management concepts; using SAS in the environment of Unix/Linux; leading projects, including completing programming tasks independently at a project level, following program-wide standards & suggesting /developing additional standards, & engaging key stakeholders; working with CDISC standards including SDTM & ADaM as well as their implementations; working with ePRO, RECIST /irRECIST standard in Oncology trials; using CDISC Controlled Terminology; generating e-Sub packages for regulatory submissions; using define.xml version 2.0. & Pinnacle 21 to evaluate the compliance in SDTM/ADaM datasets & companying data definition documents; & ensuring process compliance & deliverable quality.