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Principal Statistical Programmer
SDC (Statistics & Data Corporation). Provide statistical programming support for clinical trials .
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide statistical programming support for clinical trials
- Perform or oversee statistical programming for clinical trial analysis and reporting on complex, large-scale projects
- Apply statistical methods and provide programming expertise to project teams
- Review Statistical Analysis Plans before programming analyses
- Lead development of SAS macros and utilities
- Generate tables, listings, and figures according to protocols, Statistical Analysis Plans, and client requests
- Participate in statistical program validation and quality control
- Develop or review SDTM aCRF and specifications and ADaM specifications
- Program and validate CDISC SDTM and ADaM datasets
- Review Pinnacle 21 reports for CDISC and FDA compliance
- Develop define.xml, study data reviewer guides, and analysis dataset reviewer guides
- Identify study priorities and communicate with project teams and management
- Manage programming timelines, budgets, client expectations, quality, documentation, and project completion
- Participate in study team meetings
- Collaborate with Clinical Operations, Project Management, and Data Management
- Review study documents including CRFs, edit check specifications, and database design specifications
- Program data-cleaning checks to support Data Management
- Participate in installation and validation of statistical software packages
- Develop and maintain infrastructure for SAS datasets and SAS code
- Mentor junior statistical programmers and provide oversight of their work
- Follow SDC procedures, sponsor requirements, quality systems, data-integrity requirements, and business ethics standards
- Contribute to statistical programming standard operating procedures
- Perform other related duties and maintain compliance with business and regulatory requirements
Requirements
What you’ll need- Strong analytical skills and ability to process scientific and medical data
- Very strong SAS programming skills, including SAS/Base, SAS/Stat, SAS Macros, and SAS/Graph
- Strong problem-solving skills
- Ability to work independently
- Excellent knowledge of statistical programming
- Proficiency in manipulating and analyzing SAS data
- Ability to identify data issues, present problems, and implement solutions quickly
- Ability to communicate technical concepts clearly to non-statistical colleagues
- Good organizational and time management skills, with ability to multitask
- Familiarity with clinical trial design and analysis activities
- Basic knowledge of FDA/CFR and ICH/GCP regulatory guidelines
- Expert knowledge of CDISC SDTM and ADaM data models
- Very strong interpersonal communication, presentation, and leadership skills
- Bachelor’s degree in computer science, statistics, or another related scientific field and at least eight years of relevant professional experience; or an equivalent combination of relevant education and/or experience
- SAS Base, Advanced, and Clinical Trials Certification is preferred
Benefits
Comp & perks- Competitive pay
- Generous time off
- Career advancement and growth opportunities
- Flexible work schedule
- Engaging work culture
- Employee benefits
- Employee recognition program
- Fun and engaging activities through SDC’s culture club
- Positive work/life balance