Senior Principal Programmer

CG Oncology

3d•$190,000 - $210,000•Remote

About The Position

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. The Senior Principal Programmer serves 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.

Requirements

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 overseeing CROs and global programming teams

Nice To Haves

experience with R and modern analytics platforms preferred

Responsibilities

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.
Serve as the programming subject matter expert for complex analyses, integrated summaries, and submission activities.
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.
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.
Serve as a technical resource during regulatory submissions, inspections, and health authority interactions.
Evaluate evolving industry standards and regulatory guidance and implement best practices within the organization.
Support preparation and review of electronic submission packages and associated datasets.
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.
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.
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.