About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

The Principal Clinical Data Analyst will be responsible for creating fit-for-purpose analyses, visual data displays and dashboards from diverse data types to aid in internal data consumption and decision-making. This position will report into the VP of Clinical Operations and will interact regularly with diverse stakeholders across the organization. Demonstrated abilities to prioritize work; to understand internal business, data and decision-making needs; and to communicate and collaborate with key stakeholders both within Data Management and beyond (research, translational science, clinical science, clinical operations, safety, medical affairs and commercial) are essential. This is a unique opportunity to join a growing team investigating a diverse portfolio of immuno-oncology therapeutics. The ideal candidate will come with industry experience working in a regulated environment while also demonstrating know-how, flexibility and scientific curiosity to drive creative approaches to both formal and exploratory work.

Location: Remote

Essential Functions

• Lead statistical and programming and interact with clients and internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.
• Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling and testing, and analysis and reporting.
• Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
• Serve as a principal level Biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.
• Review and provide input to clinical data management deliverables including, but not limited to, the following: electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Management Plan, and Data Review Plan (and the ongoing data review tables, listings, and figures [TLFs] in accordance with the Plan).
• Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others.
• Review and confirm ADaM dataset specifications. Perform quality control (QC) activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
• Perform hands on statistical analysis and modeling; maintain expertise in state-of-the-art statistical methodology and regulatory requirements.
• Validate core statistical TLFs programmed by Statistical Programmers and/or Biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall QC review on statistical deliverables before they are released to the clients.
• Provide statistical consultation to medical and clinical trial personnel for the publication of trial results; participate in the writing of abstracts, manuscripts, posters, and presentations. Generate validated, reproducible, visualizations and analysis using open-source software packages or tools to replicate more formal analyses for the purpose of clinical trial planning and design, internal data review, go/no go decision-making and external publications or data releases
• Standardize and internalize current dashboards to provide semi-automation to full automation where appropriate
• Explore other open-source Data Science languages such as Tableau in fit-for-use analytical environment
• Create integrated data analyses pooling data across various clinical trials or with other relevant data sources to meet business needs (e.g., real-world data analyses, tumor or indication-specific translational questions, site monitoring, safety signal detection, go/no-go decision-making), as appropriate
• Develop therapeutic area landscape and benchmark analyses to facilitate discussions on new target selection, clinical development and commercialization strategies
• Build and maintain data pipelines to automate data processing tasks

Qualifications

• Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience
• Minimum six (6) years of biotechnology. pharmaceutical or CRO experience, with oncology experience preferred
• Programming experience in R or Python or similar language is a must as is experience with data display and dashboard tools such as R-Shiny, Spotfire, and Tableau (or similar)
• Familiarity with reproducibility, traceability and containers (Docker) strongly preferred
• Knowledge of clinical CDISC data standards and associated requirements of working in validated environments strongly preferred
• Demonstrated ability to rapidly adapt to changing project and strategic requirements
• Interest in continuing education, particularly in the areas of business knowledge as well as technology trends for producing analyses and visualizations (particularly with an eye towards reproducibility or interactivity)
• Takes a fit-for-purpose mindset to daily work as well as long-term visioN

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES   
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce.  These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire.  While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS –In 2025 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

CG Oncology is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.