Senior Principal Programmer

🕒 3 dias atrás

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CG Oncology

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2010

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $120.000.000 Series E em 2022-11

Biotechnology • Healthcare Insurance • Pharmaceuticals

A CG Oncology é uma empresa biofarmacêutica clínica em estágio avançado, focada no desenvolvimento e comercialização de imunoterapias oncolíticas inovadoras para pacientes com câncer de bexiga. O principal produto em investigação da empresa, o cretostimogene grenadenorepvec, visa proporcionar uma opção terapêutica que poupa a bexiga, melhorando a qualidade de vida dos pacientes acometidos. Com estudos clínicos em andamento destacando os potenciais benefícios de suas terapias, a CG Oncology busca atender as necessidades não atendidas no tratamento do câncer de bexiga.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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