Senior Director managing operations of the Primary Care Institute at Cleveland Clinic. Collaborating with leaders to support patient care objectives and ensure safe operations.
About the role
- Associate Director of Statistical programming leading programming activities in a dynamic environment at ClinChoice. Overseeing processes and ensuring high-quality deliverables for regulatory submissions.
Responsibilities
- Lead programming strategy across multiple clinical studies and development programs.
- Oversee and manage internal programmers and external vendors/CRO partners.
- Establish and maintain programming standards, processes, and best practices.
- Support planning, timelines, and resourcing for all programming activities.
- Provide oversight and hands-on support for the development and validation of SDTM, ADaM datasets.
- Ensure all deliverables meet regulatory, statistical, and quality requirements.
- Guide the implementation of programming workflows using SAS and/or R.
- Drive automation, reproducibility, and process efficiency within the programming team.
- Partner closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams.
- Serve as a key programming representative in study team meetings.
- Support regulatory submissions, including eCTD-ready deliverables, reviewer guides, and traceability documents.
Requirements
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
- 8–12+ years of experience in clinical programming within pharma/biotech or CRO.
- Strong proficiency in SAS, with experience in R being a strong plus.
- Expert-level knowledge of CDISC standards (SDTM, ADaM).
- Experience managing or overseeing programming teams and external vendors.
- Proven track record supporting regulatory submissions (FDA, EMA, PMDA, etc.).
- Excellent communication, leadership, and project management skills.
Benefits
- Health insurance
- Professional development
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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