Statistical Programming Co-Lead Clinical Trials

• Co-lead (with supervision), coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.

• Co-author basic CDISC ADaM (analysis data model) analysis data set specifications including the identification of potential data issues or areas of critical data examination.

• Works with statistics on defining and documenting programming endpoint algorithms across a study, drug program.

• Manage under supervision the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (input to reviewer's guides, annotated CRF, define and XPTs); works with SMEs in SSM to ensure compliance to ESUB standards.

• Participate in efforts to remedy departmental inefficiencies in conjunction with QPT.

• Serve as the Statistical Programming co-lead to achieve milestones for a study; collaborates with PL and/or manager on issues or resource needs.

• Verify program consistency and usage of data, analysis and submission standards within a study in consultation with data standards, statistical submissions management, and the data strategy plan.

• Inform internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

Requirements

• Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred
• 2+ years relevant work experience within an organization with a focus on data management and analysis
• 2+ years SAS Base programming with 5+ years using SAS STAT, GRAPH and MACRO
• 2+ years relevant industry experience
• 2+ years clinical trial experience
• 2+ years clinical database experience
• CDISC and/or submissions experience
• Some knowledge of drug development process and clinical trials
• Some knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
• Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
• Some familiarity AI and ML concepts

🔍 ATS Optimization Keywords
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Hard Skills

• SAS Base programming
• SAS STAT
• SAS GRAPH
• SAS MACRO
• CDISC ADaM
• statistical programming
• programming endpoint algorithms
• electronic submissions (ESUB)
• data management
• data analysis

Soft Skills

• coordination
• collaboration
• communication
• problem-solving
• resource management
• oversight
• review
• timeliness
• efficiency improvement
• status reporting