Key skills
PythonSQLRAIAnalyticsStatistical AnalysisLeadershipStakeholder ManagementCommunicationCollaboration
About this role
Role Overview
- Provide leadership and oversight for statistical programming activities across multiple clinical studies and development programs.
- Serve as the programming lead for assigned programs and represent Statistical Programming on cross-functional development teams.
- Develop and implement programming strategies that support clinical development objectives, regulatory submissions, and operational efficiency.
- Oversee the development, validation, and delivery of SDTM, ADaM, TLFs, define.xml files, reviewer guides, and other submission-related deliverables.
- Ensure programming deliverables are completed with high quality, on schedule, and in compliance with regulatory requirements and company standards.
- Drive the development, maintenance, and governance of programming standards, tools, templates, and best practices.
- Act as a subject matter expert on CDISC standards, regulatory submission requirements, and programming methodologies.
- Collaborate with Biostatistics to ensure efficient implementation of Statistical Analysis Plans and consistency of statistical deliverables.
- Contribute to submission strategies and support regulatory filings, including NDA, BLA, and MAA submissions.
- Drive continuous improvement initiatives, automation strategies, and adoption of innovative technologies to improve programming efficiency and quality.
- Evaluate and promote appropriate use of AI-assisted development tools, automation frameworks, and modern analytics technologies within the programming environment.
- Mentor, coach, and develop statistical programmers while fostering technical excellence and professional growth.
Requirements
- Bachelor's, Master's, or equivalent degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related quantitative discipline.
- 10+ years of statistical programming experience within the pharmaceutical or biotechnology industry, oncology preferred.
- Demonstrated experience leading programming activities across multiple clinical development programs.
- Strong expertise in SAS programming, including Base SAS, Macro programming, SQL, and clinical reporting.
- Experience with R, Python, or other modern programming languages is desirable.
- Deep knowledge of CDISC standards, including SDTM, ADaM, define.xml, controlled terminology, and submission requirements.
- Experience supporting global regulatory submissions and interactions with health authorities.
- Strong understanding of clinical trial processes, GxP requirements, and industry best practices.
- Experience implementing automation, standardization, and process improvement initiatives.
- Interest in emerging technologies and practical applications of AI-assisted programming and automation tools.
- Excellent communication, collaboration, leadership, and stakeholder management skills.
Tech Stack
- Python
- SQL
Benefits
- Continuous learning opportunities
- A culture where every voice is heard