Statistical Programmer
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* We are seeking skilled Statistical Programmers (Sr. and Principal levels) to ensure the accuracy, integrity, and regulatory compliance of statistical programming across various clinical trial projects. You will develop, validate, and maintain complex analysis programs, provide advanced technical leadership, and drive process improvements within the statistical department.
Key Responsibilities
- Programming Deliverables: Plan, coordinate, and execute the programming, testing, and documentation of statistical programs to generate tables, figures, listing summaries (TFLs), and derived analysis datasets (Safety and/or Efficacy).
- CDISC Standards Validation: Ensure full compliance with CDISC standards (SDTM and ADaM), author/review ADaM specifications, and utilize Pinnacle 21 (P21) for dataset validation and regulatory readiness.
- Regulatory Documentation: Create and maintain submission documentation, including Analysis Data Reviewers Guides (ADRG) and Define.xml.
- Process Tool Development: Leverage SAS and R programming for statistical analyses, data manipulation, reporting, automation, and the implementation of innovative programming solutions.
- Leadership Collaboration: Provide technical guidance on statistical methodologies, mentor junior programmers, collaborate with cross-functional teams, and serve as a statistical team lead for complex studies. Mandatory Requirements Qualifications
-
Education:
Bachelors or Masters degree in Statistics, Computer Science, or a related field.
- R Programming: Minimum 1 year of hands-on R programming experience in a regulated environment.
- Technical Expertise: Strong proficiency in SAS programming, CDISC SDTM/ADaM standards, ADaM specification writing, and P21 validation tools.
- Analysis
Experience:
Proven background in Safety and/or Efficacy analysis programming within clinical trials, including the creation of efficacy datasets and outputs.
- Core Competencies: Strong project management, analytical, problem-solving, and communication skills with the ability to lead teams and meet strict regulatory deadlines. This job is provided by Shine.com
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