A global research consulting group providing 360° support & services across all facets of clinical outcomes research.

Principal Statistical Programmer

Software EngineerSoftware EngineerFull TimeRemoteTeam 51-200H1B SponsorCompany Site LinkedIn

Location

United States

Posted

34 days ago

Salary

Not specified

Bachelor Degree8 yrs expEnglish

Job Description

• Meetings and communications • Generate SDTM and ADaM specifications • Generate & QC assigned dataset domains • Support submission activities • Generate TLFs (patient profile, interim analysis, annual summary report, final CSR) • Prepare SDTM define files and reviewer guide(s) and ADaM define files and reviewer guide(s) • Handling Data transfers to sponsor (or other designee) • Publication support • Ad hoc tasks/activities requested by sponsor • Writing SAS macros and other utilities and tools • Reviewing documents/specifications/output created by sponsor’s Partner CROs • Maintenance of associated tracking and validation documentation

Job Requirements

At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
8+ years of experience as a Statistical Programmer in clinical Development environment
Excellent SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
Prior working experience with Oncology studies
Must be able to work independently
Outstanding communication skills (written and verbal) and strong leadership skills