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Statistical Programmer II
Everest Clinical Research. Develop and review SDTM and ADaM dataset specifications, annotated CRFs, define.xml, reviewer’s guides, and related documents .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in developing and validating SDTM and ADaM datasets, along with proficiency in SAS programming for statistical reporting and data integrity checks. Strong understanding of clinical trial standards and regulatory requirements is essential.
Highest-signal resume keywords
SAS ProgrammingSDTM Dataset DevelopmentADaM Dataset DevelopmentCDISC Conformance ChecksStatistical Analysis
ATS Keywords
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Hard Skills
Statistical ProgrammingData AnalysisData CleaningData ReconciliationStatistical Output ReportingClinical Study Report SupportRegulatory Safety ReportingData Listings GenerationSummary Tables CreationGraph Generation
Tools & Technologies
SASDefine.xmlAnnotated CRFsReviewer’s Guides
Certifications & Qualifications
SAS Certified Base ProgrammerSAS Certified Advanced ProgrammerSAS Certified Clinical Trials Programmer
Industry Keywords
Clinical TrialsPharmaceutical ResearchRegulatory RequirementsIndustry StandardsSponsor-Specific Requirements
About the role
Key responsibilities & impact- Develop and review SDTM and ADaM dataset specifications, annotated CRFs, define.xml, reviewer’s guides, and related documents
- Program and validate SDTM and ADaM datasets
- Perform CDISC conformance checks and address findings
- Develop SAS programs for statistical output reports based on SAP and TLG mock-up shells
- Provide programming support for Clinical Study Reports, integrated safety and efficacy analyses, regulatory safety reports, ad-hoc requests, and exploratory analyses
- Develop and maintain SAS programs for database integrity checks and ongoing data cleaning
- Reconcile CRF and non-CRF data and perform non-CRF data integrity checks
- Generate data listings, summary tables, graphs, and Patient Profiles
- Document data and programming information according to SOPs and WIs
- Achieve audit readiness and defined statistical programming performance indicators
- Maintain knowledge of industry standards and regulatory requirements
- Develop and provide expertise in other programming and system administration areas when required
Requirements
What you’ll need- Master’s or Ph.D. degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, or computer sciences
- SAS certified Base, Advanced, and Clinical Trials Programmers are highly preferred
- Exposure/experience in clinical trial statistical programming and/or data analysis is desirable
- Current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements
- Knowledge of clinical trial Sponsor-specific requirements when applicable
- Compliance with Everest company-specific and clinical trial Sponsor-specific training requirements
Benefits
Comp & perks- Equal opportunity and accommodations for candidates with disabilities
- Remote or hybrid work options for the Taiwan location