Biostatistical Programming Senior Manager
Based in United StatesFull-TimeManager
SalaryCompetitive annual salary range approximately 151,838.05 USD to 205,427.95 USD
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Job Details
- Experience
- Bachelor’s degree with 6+ years, Master’s degree with 4+ years, or Doctorate with 2+ years of relevant experience; At least 10 years of experience in clinical research, drug development, or statistical programming.
- Required Skills
- Project ManagementData Analysis
Requirements
- Bachelor’s degree with 6+ years, Master’s degree with 4+ years, or Doctorate with 2+ years of relevant experience (or equivalent combinations)
- At least 10 years of experience in clinical research, drug development, or statistical programming in a regulated environment
- Strong expertise in statistical programming languages, particularly SAS or similar procedural languages
- Solid understanding of real-world data sources such as claims and electronic medical records
- Proven leadership experience managing technical teams and complex projects
- Strong background in project planning, process improvement, and cross-functional collaboration
- Knowledge of clinical drug development lifecycle and regulatory standards
- Ability to develop policies, SOPs, and controlled documentation in a research environment
- Strong communication, problem-solving, and stakeholder management skills
- Experience with Unix systems and software development environments preferred
Responsibilities
- Lead, manage, and develop a team of statistical programmers supporting real-world evidence and observational research projects
- Oversee end-to-end programming activities including study planning, execution, timelines, and resource allocation
- Design, review, and approve programming plans, analysis datasets, and technical specifications
- Develop and validate programs, macros, and utilities to generate analysis-ready datasets and outputs in Unix-based environments
- Ensure compliance with internal standards, SOPs, regulatory requirements, and audit readiness across all deliverables
- Collaborate with cross-functional stakeholders including data management, clinical operations, and biostatistics teams
- Review vendor proposals and manage outsourced programming resources when applicable
- Contribute to process improvement, standardization, and automation initiatives within the programming function
- Support recruitment, training, and development of programming staff
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