At least 8 – 10 years of experience in statistical programming with clinical data and SAS
Experience in oncology therapeutic area required.
Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros
CDISC proficiency required
SAS/GRAPH experience (Kaplan-Meier plots, swim lane plots) strongly preferred
Responsibilities:
Provide oversight development of datasets (SDTMs/ADaMs) in CDISC compliant format by CROs including clear documentation of the process that was followed in the form of specifications, trackers and checklists.
Generate and/or review of SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents and reviewers’ guides per CDISC and FDA specifications and guidelines.
Accountable for oversight of statistical programming deliverables for inhouse and outsourced projects.
Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
Independently develop SAS or other programs and specifications for production of output to support study needs including publications, safety reporting, ad hoc analyses in a timely fashion
Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
Oversee and manage work of other junior programmers.
Develop and/or validate standard macros to automate output production.
Adhere to company SOPs and department guidelines.
Work concurrently on multiple projects
Troubleshoot technical and project issues.
Help with infrastructure development of the department.
Communicate effectively with internal cross-functional groups and external partners.