Senior Statistical Programmer

Everest Clinical Research

. Lead resolution of day-to-day work-related issues and problems .

Posted 9/30/2026full-timeTaipei City • TaiwanSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical programming, particularly in developing and validating SDTM and ADaM datasets while ensuring compliance with CDISC standards. Proven ability to lead projects, perform quality checks, and maintain documentation according to corporate guidelines.

Highest-signal resume keywords

Statistical ProgrammingSDTM Dataset DevelopmentADaM Dataset ValidationCDISC Standards CompliancePinnacle 21 Validation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingSDTM Dataset DevelopmentADaM Dataset ValidationCDISC Standards ComplianceDefine.xml File CreationData Integrity ChecksStatistical TLG ReviewMacros DevelopmentQC ReviewRegulatory Submission Programming

Soft Skills

Project ManagementClient Trust BuildingProblem ResolutionTeam LeadershipCommunication

Tools & Technologies

Pinnacle 21Statistical Programming UtilitiesMacros

Industry Keywords

Clinical TrialBiostatisticsEpidemiologySOPsWIs

About the role

Key responsibilities & impact

Lead resolution of day-to-day work-related issues and problems
Ensure quality of deliverables and improve statistical programming efficiency and productivity
Lead assigned projects using project management skills and statistical programming techniques
Deliver high-quality project deliverables on time and build client trust and repeat business
Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE
Perform QC reviews of dataset specifications prepared by others
Program and validate SDTM and ADaM datasets
Perform CDISC standard-compliant checks on SDTM and ADaM datasets
Generate, review, and resolve Pinnacle 21 validation issues
Perform additional QC checks using company Working Instruction checklists
Review statistical TLGs for overall quality and consistency before internal or client delivery
Create and QC define.xml files
Participate in or lead programming teams supporting regulatory submission activities
Maintain expertise in statistical programming utilities and macros
Develop new macros and utilities
Program and perform QC/validation of complex data integrity checks for data quality and scientific data surveillance
Complete job-required and project-specific training
Comply with Everest and trial sponsor policies, SOPs, and WIs
Document data and programming information according to corporate SOPs and guidelines
Archive SDTM and ADaM datasets and programming information according to archival SOPs and guidelines

Requirements

What you’ll need

Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, or Computer Sciences with at least four years’ experience in clinical trial statistical programming
OR Bachelor’s degree in the above fields with at least six years’ experience in clinical trial statistical programming
Experience developing and reviewing SDTM and ADaM dataset specifications
Experience programming and validating SDTM and ADaM datasets
Knowledge of CDISC standards and compliant checks
Experience generating, reviewing, and resolving Pinnacle 21 validation issues
Experience creating and reviewing define.xml files
Experience with statistical TLG quality and consistency reviews
Experience with regulatory submission-related programming activities
Expertise in statistical programming utilities and macros
Ability to develop macros and utilities
Experience programming and validating complex data integrity checks
Ability to complete required training and comply with company and sponsor policies, SOPs, and WIs
Ability to document and archive clinical trial data and programming information according to corporate procedures

Benefits

Comp & perks

Opportunities to work remotely or hybrid in accordance with the Work from Home policy
Equal opportunity commitment
Recruitment accommodations for candidates with disabilities upon request