Senior Manager, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and engage in the development and validation of datasets, tables, figures, and listings that support clinical trial analysis and reporting.

• Develop SAS programs and AI-assisted programming solutions for comprehensive statistical programming tasks, including SDTM, ADaM, and TFL content.

• Conduct programming validation and quality assessments of analysis datasets, programming outputs, and AI-generated deliverables.

• Offer programming support, strategies, standards, specifications, programmed analyses, and AI-enabled methodologies for project teams.

• Oversee or assist in the preparation of submissions, deliverables, and regulatory responses.

• Examine statistical analysis plans, data presentation plans, and data review plans to ensure programming alignment and impact.

• Create or review validation plans for programming deliverables.

• Collaborate with vendors regarding standards, conventions, specifications, file transfers, and AI-enabled programming practices.

• Guarantee deliverable quality, regulatory compliance, and adherence to SOPs and operational practices.

• Recognize opportunities for efficiency, consistency, automation, and quality enhancements.

• Independently manage programming assignments with minimal supervision.

• Lead or take part in initiatives for process improvement, standards, automation, and the adoption of AI.

• Supervise contract workers and provide guidance on programming standards, quality expectations, and AI-enabled workflows.

• Assess, implement, and promote emerging AI-enabled programming capabilities while ensuring quality, traceability, and regulatory compliance.

⛳️ Requirements

• Expertise in SAS, R (preferred), and AI-enabled programming tools.

• Familiarity with CDISC standards, relational database architectures, and industry data benchmarks.

• Proficient with MS Office, XML, Pinnacle 21, and cutting-edge AI-enabled technologies.

• Capability to generate submission-ready ADaM datasets, define.xml files, reviewer guides, and other regulatory materials.

• Strong understanding of regulatory, industry, and technological standards and requirements for AI-enabled tools in regulated environments.

• Knowledgeable in drug development, clinical trials, medical terminology, statistical analysis plans, and protocol designs.

• Ability to collaborate with clinical team members, vendors, and cross-functional stakeholders.

• Capacity to identify improvements in productivity, quality, consistency, and automation.

• Proficient in evaluating, validating, and supervising AI-generated outputs for accuracy, reproducibility, traceability, and compliance.

• Ability to support the adoption of new technologies, standards, and AI-enabled programming practices.

• Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field preferred.

• A minimum of 4 years of experience in the pharmaceutical industry preferred.

• Experience in supporting therapeutic areas related to rare diseases and/or PK/PD analyses preferred, but not mandatory.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-sponsored basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Assistance with student loans.

• Generous 401(k) matching.

• Flexible time off policies.

• Paid holidays.

• Paid leave programs.

• Opportunity for incentives.