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Overview

Company
CG Oncology
Location
all cities, ME 22
Employment type
On-site
  • Regional Vice President, New Business Sales (22)
  • HR Generalist (22)
  • Semiconductor Associate IP Attorney (22)
  • Data Scientist (22)
  • Remote Talent Acquisition Consultant - Healthcare Network Specialist (43)
  • Sr. Electrical Engineer - Grid Interconnection - Remote (26)
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C
CG OncologyVerified Employer

Business Services & Consulting • all cities, ME 22

Associate Director, Biostatistics (22)

all cities, ME 22On-sitePosted 1 day ago
Business Services & Consulting

About the Role

Associate Director, Biostatistics

The Associate Director, Biostatistics provides statistical leadership and technical expertise across one or more clinical development programs.This individual is responsible for the design, analysis, interpretation, and reporting of clinical studies and contributes to development and regulatory strategies through close cross functional collaboration.The Associate Director will collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, Data Management, Statistical Programming, Translational Sciences, Medical Affairs, and external partners to support critical development and business decisions.

This role requires a strong understanding of oncology drug development, regulatory strategy, and statistical methodologies applicable to registration-enabling studies.

Location: Remote

Essential Functions
  • Guide Study Design and Execution of Clinical Trials
  • Author/Review Regulatory Documents and Support Regulatory Strategies
  • Data Interpretation and Support Decision Making
  • Process Improvements
  • Oversee CROs and External Partners
  • Mentor Team Members
Qualifications
  • MS or PhD in Biostatistics or related field
  • 8+ years of experience in pharmaceutical, biotechnology, or CRO industry
  • 5+ years supporting oncology clinical development programs
  • Direct experience supporting regulatory submissions (BLA, NDA, MAA, or equivalent)
  • Experience interacting with FDA and/or global health authorities
  • Experience managing CROs and external statistical vendors
  • Demonstrated success leading cross-functional teams and influencing development strategy
  • Regulatory submission experience
  • Strong SAS/R expertise

Total Rewards

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

Well-Being Benefits

  • 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

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.

Associate Director, Biostatistics

The Associate Director, Biostatistics provides statistical leadership and technical expertise across one or more clinical development programs.This individual is responsible for the design, analysis, interpretation, and reporting of clinical studies and contributes to development and regulatory strategies through close cross functional collaboration.The Associate Director will collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, Data Management, Statistical Programming, Translational Sciences, Medical Affairs, and external partners to support critical development and business decisions.

This role requires a strong understanding of oncology drug development, regulatory strategy, and statistical methodologies applicable to registration-enabling studies.

Location: Remote

Essential Functions
  • Guide Study Design and Execution of Clinical Trials
  • Author/Review Regulatory Documents and Support Regulatory Strategies
  • Data Interpretation and Support Decision Making
  • Process Improvements
  • Oversee CROs and External Partners
  • Mentor Team Members
Qualifications
  • MS or PhD in Biostatistics or related field
  • 8+ years of experience in pharmaceutical, biotechnology, or CRO industry
  • 5+ years supporting oncology clinical development programs
  • Direct experience supporting regulatory submissions (BLA, NDA, MAA, or equivalent)
  • Experience interacting with FDA and/or global health authorities
  • Experience managing CROs and external statistical vendors
  • Demonstrated success leading cross-functional teams and influencing development strategy
  • Regulatory submission experience
  • Strong SAS/R expertise

Total Rewards

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

Well-Being Benefits

  • 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

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.

What You'll Do

Guide Study Design and Execution of Clinical Trials
Author/Review Regulatory Documents and Support Regulatory Strategies
Data Interpretation and Support Decision Making
Process Improvements
Oversee CROs and External Partners
Mentor Team Members

Skills & Technologies

Business Services & Consulting

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