Senior Principal Programmer

About the role

The Senior Principal Programmer provides strategic and technical leadership for statistical programming activities across clinical development programs. This role is responsible for the development and delivery of high-quality, submission-ready datasets, analyses, and programming deliverables that support regulatory submissions and critical business decisions.

Serve as a subject matter expert in CDISC standards, regulatory requirements, and programming best practices, while partnering cross-functionally to drive operational excellence, innovation, and inspection readiness across the development portfolio.

Essential Functions

• Lead Statistical Programming Strategy and Execution

• Provide technical leadership for statistical programming activities across multiple clinical development programs.

• Lead the development, validation, and maintenance of SDTM and ADaM in accordance with CDISC standards and regulatory requirements.

• Oversee creation and maintenance of specifications, Define.xml packages, and submission-ready deliverables.

• Ensure programming deliverables support study objectives, statistical analyses, and regulatory submission requirements.

• Author, Review, and Validate Programming Deliverables

• Lead the design, development, validation, and documentation of statistical programs supporting clinical study reporting and regulatory submissions.

• Develop and review analysis datasets, tables, listings, figures (TLFs), patient profiles, and ad hoc analyses.

• Ensure programming deliverables meet quality, traceability, reproducibility, and regulatory compliance standards.

• Establish and maintain programming specifications, validation plans, and quality control procedures.

• Support inspection readiness and audit activities through comprehensive documentation and traceability.

• Comply with industry and regulatory standards

• Provide expertise in FDA, EMA, ICH, CDISC, and other applicable regulatory requirements related to clinical data standards and submissions.

• Lead implementation and governance of SDTM, ADaM, and Define.xml standards across development programs.

• Support preparation and review of electronic submission packages and associated datasets.

• Drive Programming Innovation and Process Improvements

• Lead development of departmental programming standards, macros, utilities, and reusable tools that improve efficiency and consistency.

• Identify opportunities to automate workflows, improve data quality, and enhance operational scalability.

• Drive continuous improvement initiatives across statistical programming processes and systems.

• Evaluate and implement emerging technologies and programming methodologies to support clinical development objectives.

• Champion programming excellence, reproducibility, and inspection readiness across the organization.

• Oversee CROs and External Partners

• Provide strategic oversight of CRO statistical programming activities and external programming resources.

• Review vendor deliverables for quality, consistency, regulatory compliance, and adherence to timelines.

• Establish programming expectations, standards, and governance processes with external partners.

• Monitor vendor performance and proactively identify and mitigate risks to program deliverables.

• Serve as the primary programming representative for outsourced activities and cross-functional collaborations.

• Mentor and Develop Team Members

• Provide technical mentorship and guidance to programmers across all levels of experience.

• Lead training initiatives related to CDISC standards, programming methodologies, validation practices, and submission requirements.

• Foster a culture of continuous learning, collaboration, innovation, and quality.

• Support departmental resource planning, talent development, and succession planning activities.

• Serve as a recognized technical leader and trusted advisor across Clinical Development, Biostatistics, Data Management, and Regulatory Affairs.

Qualifications

• BS/MS in Computer Science, Statistics, Biostatistics, Mathematics, or related field

• 10+ years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry

• 5+ years leading complex programming activities across multiple clinical programs

• Extensive experience supporting NDA, BLA, MAA, or equivalent regulatory submissions

• Deep expertise in CDISC SDTM, ADaM, and Define.xml standards

• Advanced SAS programming expertise; experience with R and modern analytics platforms preferred

• Experience overseeing CROs and global programming teams