· Design, develop, and validate statistical programs, datasets, and reporting outputs (tables, listings, and figures) for clinical trials in alignment with project requirements and regulatory standards.
Build and maintain analysis datasets (ADaM) and study data tabulation models (SDTM) in compliance with CDISC standards, ensuring traceability and submission readiness.
Develop, maintain, and optimize SAS programs, macros, and templates for clinical data review, reconciliation, and reporting to support both production and quality control (QC) workflows.
Lead the review of key study documentation including statistical analysis plans (SAP), annotated CRFs, mock shells, and programming specifications to ensure consistency and alignment across deliverables.
Engineer robust, auditable programming workflows and data traceability pipelines, adhering to Good Clinical Practices (GCP), ICH guidelines, and internal standard operating procedures (SOPs).
Collaborate with biostatisticians, data managers, and clinical teams to identify programming needs, define deliverable requirements, and ensure timely, high-quality data outputs for regulatory submissions and publications.
Create regulatory submission documents such as Define.xml, SDRG, and ADRG to support clinical study reports (CSRs) and electronic data submissions.
Support external data integration and reconciliation through programmatic validation routines and automated data cleaning processes, enhancing the quality and reliability of study datasets.
Participate in the continuous improvement of statistical programming standards, processes, and reusable assets to drive efficiency and consistency across studies and therapeutic areas.
Provide mentorship and technical leadership to junior statistical programmers by conducting code reviews, sharing best practices, and contributing to group knowledge development.
MS with 2 years of Experience
Requires Master''s degree or equivalent in Computer Science, Statistics or closely related field
Contact Person: hr.us@acldigital.com
Numbers & Facts
Location
King of Prussia, PA
Skills
Analysis Skillsunmatched
Best Practicesunmatched
Biostatisticsunmatched
Case Report Form (CRF)unmatched
Clinical Dataunmatched
Clinical Data Interchange Standards Consortium (CDISC)unmatched
Clinical Supportunmatched
Clinical Trialunmatched
Code Reviewsunmatched
Computer Scienceunmatched
Continuous Improvementunmatched
Data Cleaningunmatched
Data Managementunmatched
Data Modelingunmatched
Data Qualityunmatched
Data Setsunmatched
Documentationunmatched
GCP (Good Clinical Practices)unmatched
Knowledge Managementunmatched
Mentoringunmatched
Needs Assessmentunmatched
Production Controlunmatched
Production Supportunmatched
Publicationsunmatched
Quality Controlunmatched
Reconciliationunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Regulatory Submissionsunmatched
Requirements Managementunmatched
SAPunmatched
Standard Operating Procedures (SOP)unmatched
Statistical Analysis System (SAS)unmatched
Statistical Programming Languagesunmatched
Statisticsunmatched
Technical Leadershipunmatched
Time Managementunmatched
Traceabilityunmatched
Training Data Setsunmatched
XML (EXtensible Markup Language)unmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.