Senior Principal Programmer

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CG Oncology

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11 - 50 Mitarbeiter

Gegründet 2010

🧬 Biotechnologie

⚕️ Krankenversicherung

💊 Pharmazie

💰 €120.000.000 Series E im 2022-11

Biotechnology • Healthcare Insurance • Pharmaceuticals

CG Oncology ist ein biopharmazeutisches Unternehmen im Spätstadium der klinischen Entwicklung, das sich auf die Entwicklung und Kommerzialisierung innovativer onkolytischer Immuntherapien für Patienten mit Blasenkrebs konzentriert. Das Hauptprodukt des Unternehmens, Cretostimogene Grenadenorepvec, zielt darauf ab, eine blasenerhaltende therapeutische Option bereitzustellen, um die Lebensqualität der betroffenen Patienten zu verbessern. Durch laufende klinische Studien, die die potenziellen Vorteile ihrer Therapien hervorheben, bemüht sich CG Oncology, den ungedeckten Bedarf in der Blasenkrebsbehandlung anzugehen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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