Senior Software Engineer – Applied AI
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CloudDistributed SystemsPythonReact
Principal Statistical Programmer Consultant – Oncology
ClinChoice
contract
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- 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 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 in-house 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, and 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 the 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 the infrastructure development of the department.
- Communicate effectively with internal cross-functional groups and external partners.
Requirements
- BS/BA degree in a related discipline
- At least 8 – 10 years of experience in statistical programming with clinical data and SAS
- Experience in Rare disease/Neurology therapeutic area is a plus.
- 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
- Knowledge of appropriate regulations, industry standards and guidance documents
- Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners
Benefits
- Competitive salary
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SASSAS/BaseSAS/StatSAS/MacrosSAS/GRAPHCDISCstatistical programmingdataset developmentoutput productionmacro development
Soft skills
technical leadershipproblem-solvingcommunicationcollaborationproject managementinterpersonal skillstime managementoversighttroubleshootingdocumentation
