Senior Principal Programmer

CG Oncology

Senior Principal Programmer at CG Oncology providing technical leadership in statistical programming for clinical development. Responsible for regulatory submissions and high-quality programming deliverables across multiple programs.

Posted 6/9/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $190,000 - $210,000 per yearWebsite

About the role

Key responsibilities & impact

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
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
Lead implementation and governance of SDTM, ADaM, and Define.xml standards across development programs
Evaluate evolving industry standards and regulatory guidance and implement best practices within the organization
Drive continuous improvement initiatives across statistical programming processes and systems
Review vendor deliverables for quality, consistency, regulatory compliance, and adherence to timelines
Mentor and develop team members, leading training initiatives related to CDISC standards, programming methodologies, validation practices, and submission requirements

Requirements

What you’ll need

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

Benefits

Comp & perks

HIGHLY COMPETITIVE SALARIES
ANNUAL PERFORMANCE/MERIT REVIEWS
ANNUAL PERFORMANCE BONUSES
EQUITY
SPECIAL RECOGNITION
FULLY REMOTE WORK ENVIRONMENT
REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
HOLIDAYS –In 2026 we will observe 14 holidays
RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

statistical programmingSASRCDISC SDTMCDISC ADaMDefine.xmldata validationanalysis datasetsquality control proceduresregulatory compliance

Soft Skills

technical leadershipmentoringteam developmentcommunicationcontinuous improvementtraining initiativessubject matter expertiseevaluation of standardsoversightcollaboration