Sr. Principal Analyst, Statistical Programming

Role Summary

Remote position located in the United States. The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities for internal teams and external vendors, applying data standards and delivering analysis datasets, tables, listings, figures, and electronic submission components (define.xml and XPTs) for analyses and submissions. They partner with Biostatistics to deliver high-quality, submission-ready outputs and provide input on study timelines and resource needs. The role leads a drug program team of statistical programmers, oversees vendor quality, and represents the Statistical Programming perspective to study teams and Clinical Development. It also helps implement the Data and Programming Strategy and collaborates on standard programming practices and process improvements.

Responsibilities

• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects via internal and/or external staff oversight.
• Authors 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 and/or contributing to TA level algorithms.
• Manage the end-to-end programming of deliverables through 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 to ensure compliance to eSUB standards.
• Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with DVAD and PON.
• Serves as the Statistical Programming Lead to achieve milestones for a drug program; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs.
• Verifies program consistency and usage of data, analysis and submission standards across the department in consultation with data standards, statistical submissions management and the data strategy plan.
• Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

Qualifications

• Required: Bachelor’s degree. Preferred: Masters or PhD in Statistics or Mathematics.
• Required: 10 years relevant work experience within an organization with a focus on data management and analysis.
• Required: 10+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO.
• Required: 10+ years relevant industry experience.
• Required: 10+ years clinical trial experience.
• Required: 5+ years clinical database experience.
• Required: CDISC and/or submissions experience.
• Required: Extensive knowledge of drug development process and clinical trials.
• Required: Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines.
• Required: Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages).
• Required: Familiarity AI and ML concepts.

Education

• Bachelor’s degree required; Masters or PhD in Statistics or Mathematics preferred.

Skills

• Statistical programming leadership and cross-functional collaboration.
• CDISC ADaM and analysis dataset specifications.
• End-to-end programming for regulatory submissions (CRF to ESUB).
• Data standards and quality oversight; adherence to submission standards.
• Vendor management and communication with study teams and management.
• Knowledge of SAS, UNIX, R, and imaging/genomics software packages; familiarity with AI/ML concepts.