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A global research consulting group providing 360° support & services across all facets of clinical outcomes research.
Principal Statistical Programmer
Location
California
Posted
4 days ago
Salary
0
Seniority
Lead
Job Description
Principal Statistical Programmer
Clinical Outcomes Solutions
• 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
Benefits
- Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support.
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