Senior Principal Programmer
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
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.
Responsibilities:
- 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:
- 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
Similar Jobs
Project Developer – Federal
Project Developer at NORESCO, managing complex federal energy projects with a focus on efficiency and resiliency. Collaborate with various teams to deliver tailored solutions and support sales.
Loxone Programmer, Building Automation
Loxone Programmer implementing tailored energy management solutions for hotels. Collaborating with project leads to integrate smart automation systems leveraging Loxone technology.
Solution Director – Digital Engineering
Solution Director for Digital Engineering leading digital engineering solutions and teams for defense programs. Overseeing technical accuracy and integrating advanced technologies for business opportunities.
IoT Developer
Software Engineering Technical Specialist developing solutions in IoT domains at Kyndryl. Contributing technical expertise and leadership in software engineering for cutting-edge products.
Vice President of Engineering
Vice President of Engineering overseeing the development and scaling of Pax8’s financial technology platform. Leading engineering teams to ensure compliance and drive innovation in financial transactions.
Stibo STEP Developer
Developer FullStack responsible for Stibo STEP PIM solutions at HRM. Handling implementation and high-quality data integration within the project team.
Director Engineering – AI Native
Director of Engineering leading software engineering teams at Cotiviti Payment Integrity business. Championing AI-native software delivery integrating automation and intelligent workflows.
Senior MuleSoft Developer
Senior Mulesoft Developer transforming technology into government opportunities at GDIT. Collaborating to build and maintain enterprise solutions and APIs for mission-critical projects.
GTM Developer
GTM Developer driving productivity through internal tools at Backblaze. Collaborating closely with various teams to enhance operational efficiency.
Application Developer
Senior Application Developer at Gainwell creating and maintaining cloud-native healthcare solutions. Collaborating with teams to modernize health and public sector platforms and ensure scalability, security and compliance.
MuleSoft Developer – Mid-level
MuleSoft Developer assisting clients with digital transformation solutions through programming and API integration. Collaborating with project teams to deliver effective technological solutions.
Desenvolvedor C# – Sênior
C# Developer working on evolving desktop systems for financial technology solutions. Expanding service consumption and executing specific processes in AWS environments.
Junior Developer
Junior Developer contributing to application development and maintenance for client IT systems. Collaborating in Agile teams and supporting CI/CD pipelines within a DevSecOps environment.
Manager, Demo Engineering
Manager of Global Demo Engineering at Seismic responsible for demo environment strategy and team leadership. Overseeing projects around automation tools and AI integration to enhance sales engineering performance.
Desarrollador de aplicaciones semi senior
Software Developer designing and developing scalable software solutions. Collaborating in a full cycle of development within Stefanini.
VP, Engineering
VP of Engineering at Adelaide, overseeing engineering function and driving technical strategy. Lead team in a remote-first culture focused on scalable media measurement solutions.
Desenvolvedor Delphi, Pleno – Time Fiscal
Desenvolvedor Delphi desenvolvendo soluções para a Alterdata. Participando da análise de requisitos e potencializando negócios dos clientes.
Communications Manager – Product & Engineering
Communications Manager for WD's Product and Engineering teams, designing employee-facing communications strategies. Collaborating with engineers and leaders to ensure alignment with company culture and strategic goals.
Principal Statistical Programmer
Principal Statistical Programmer at Everest Clinical Research leading complex statistical programming and validation projects in clinical trials. Coordinating teams and ensuring quality deliverables in the FDA submissions.
Developer Marketing Manager
Developer Marketing Manager engaging developer communities and enhancing Shippo’s API presence. Creating content and executing events to foster developer relationships and visibility across channels.