CG Oncology logo
CG Oncology

Attacking Bladder Cancer for a Better Tomorrow

Senior Principal Programmer

Software EngineerSoftware EngineerFull TimeRemoteSeniorTeam 11-50Since 2010H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

12 days ago

Salary

$190K - $210K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

Senior Principal Programmer

CG Oncology

• 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

Job 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 with R and modern analytics platforms preferred
  • Experience overseeing CROs and global programming teams

Benefits

  • 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

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