Overview In this role you will help shape and manage clinical analysis standards, working with stakeholders to ensure standards meet business and industry requirements. You will QC ADaM datasets, SAS programs, and documentation, and support cross-functional teams with training, compliance, and change requests. The position supports a standards repository and governs ongoing alignment with regulatory expectations. This role offers impact by enabling consistent analysis practices across clinical research programs.
Responsibilities- Define, review, QC, and maintain standard statistical requirements aligned with business needs and industry standards
- Review and QC ADaM datasets and result metadata per documented requirements
- Review and QC SAS programs and macros creating standard ADaM datasets, tables, figures, and listings
- Develop, review, and maintain documentation describing standards and related processes
- Provide support for stakeholders implementing standards including communications, training, Q&A, compliance, and usage metrics
- Coordinate standards development projects
- Manage, assess, and execute change requests
- Maintain the standards repository
Key requirements- BS/BA in statistics (preferred), computer science, mathematics, or other scientific field
- 5+ years as statistician or similar with clinical research analysis and reporting in biopharma or CRO
- Basic SAS programming knowledge with QC/validation program development experience
- Solid understanding of clinical research analysis and reporting with SAP development experience
- Basic knowledge of industry standards (ADaM and SDTM) and regulatory requirements
- Strong English verbal and written communication skills
- Experience working in a virtual team with collaboration, organization, communication, and problem-solving skills
- Ability to prioritize tasks in a fast-paced multi-project environment
- collaboration
- communication (verbal and written)
- problem-solving
- SAS programming
- ADaM specifications knowledge
- SDTM knowledge
