Senior Principal Statistical Programmer

KPS Life is hiring a Senior Principal Statistical Programmer to be dedicated to our oncology focused sponsor client.

This senior level role offers the opportunity to drive CDISC strategy (SDTM/ADaM/Define.xml), lead complex regulatory submissions (NDA/BLA/MAA), mentor programming teams, and shape innovative processes for a high-priority oncology portfolio. We’re looking for candidates with 8+ years of statistical programming experience, proven submission leadership, and deep expertise in SAS and clinical data standards.

If you’re ready to make a direct impact in oncology clinical development, reach out or apply today!

(Candidates must be legally authorized to work in the U.S. We are unable to sponsor or transfer employment visas for this position)

Position Summary

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.

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.

• Serve as the programming subject matter expert for complex analyses, integrated summaries, and

submission activities.

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.

Ensure Compliance 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.

• 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.

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.

• 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.

Professional Qualifications

Minimum Education:

BS/MS in Computer Science, Statistics, Biostatistics, Mathematics, or

related field

Minimum Experience:

• 8+ years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry
• 4+ 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