TG
Principal Statistical Programming Consultant (EU)
TechBiz Global
Contract type
Ongoing
Work mode
100% remote
Experience
Senior · 5+ years
Job description
Key details
- Perform statistical programming activities for clinical trials, including early-phase projects, indications, and publications
- Lead at least one study team, providing technical and domain expertise
- Manage and mentor a small team of 2–4 programmers (if required)
- Develop and validate SAS analysis datasets, tables, listings, and figures (TLFs) based on specifications
- Create programs for graphs and tables used in Clinical Study Reports (CSRs), safety reports, and efficacy reports
- Work on data migration from legacy datasets to standards such as CDISC or client-specific formats
- Read, interpret, and implement program specification documents
- Perform data validation and transformation according to client requirements
- Validate TLFs to ensure accuracy, quality, and compliance
- Collaborate with clients and global teams (e.g., US team) to resolve data issues, outliers, specification clarifications, timelines, and deliverables
- Follow Standard Operating Procedures (SOPs) and Quality Management Systems
- Support hiring activities by identifying skill requirements and conducting technical interviews
- Company mission
- Information not specified
Benefits
- Opportunity to work on global clinical trials
- Collaborative and supportive team environment
- Career growth and leadership opportunities
Requirements & details
- Bachelor's or Master's degree in Computer Science, Statistics, Biostatistics, Life Sciences, or related field
- Minimum 5+ years of SAS programming experience in clinical trials
- Mandatory experience in Oncology Therapeutic Area (TA)
- Experience working with clinical trial data and regulatory submissions
- Hands-on experience with CDISC standards (SDTM, ADaM)
- Experience with data migration and transformation
- Experience with TLF generation (Tables, Listings, Figures)
- Understanding of drug development lifecycle
- Understanding of regulatory requirements (e.g., FDA, EMA)
- Ability to work independently and manage multiple priorities
- Strong analytical and problem-solving skills
- Excellent communication skills (written and verbal)
- Leadership and mentoring capabilities
- experience leading small teams or study teams
- exposure to global client environments
- experience contributing to recruitment/interview processes
- SAS, CDISC
- Clinical Research