Senior Principal Statistical Programmer

kps life; United States; On-site; USD 170,000 - 210,000; Full time

Job summary

KPS Life is hiring a Senior Principal Statistical Programmer dedicated to an oncology sponsor. This role drives CDISC strategy, leads complex regulatory submissions (NDA/BLA/MAA), mentors teams, and shapes innovative processes for a high-priority oncology portfolio. 8+ years of SAS and CDISC expertise are required.

Candidates must be legally authorized to work in the United States. This position offers strategic leadership and collaboration across cross-functional teams to ensure

Qualifications

• 8+ years of statistical programming experience in pharma/biotech or CRO.
• 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; familiarity with R and modern analytics platforms.

Responsibilities

• Provide strategic and technical leadership for statistical programming across programs.
• Lead development, validation, and maintenance of SDTM and ADaM per CDISC and regulatory requirements.
• Oversee creation of Define.xml, submission-ready datasets, analyses, and TLFs.
• Ensure deliverables meet quality, traceability, and regulatory requirements.
• Support inspection readiness and regulatory audits with thorough documentation.

Skills

SAS Programming

CDISC SDTM

CDISC ADaM

Define.xml

Regulatory Submissions

Team Leadership

Mentoring

Clinical Data Standards

R

Quality Assurance

Education

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

Tools

R

Job description

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.

(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.
• 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.

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