Associate Director, Biostatistics
New
J
JobgetherBiotechnology, oncology
Based in the United States; work remotely within the United StatesFull-TimeDirector
SalaryAnnual base salary: $173,217–$209,899 for the remote position in the United States
Apply NowOpens the employer's application page
Job Details
- Experience
- PhD and at least six years of relevant industry experience, or a master's degree and at least eight years of relevant experience.
- Required Skills
- GCPR
Requirements
- Hold an advanced degree in Statistics or Biostatistics; have a PhD and at least six years of relevant industry experience, or a master's degree and at least eight years of relevant experience.
- Bring substantial biostatistics experience in the pharmaceutical or biotechnology industry, particularly in clinical drug development.
- Have experience supporting oncology clinical trials and knowledge of statistical methods relevant to cancer research and clinical development.
- Have practical experience applying Bayesian statistical methods in clinical development.
- Demonstrate knowledge of clinical trial design, statistical analysis methodologies, dose-finding strategies, and clinical data interpretation.
- Be proficient in SAS, R, and EAST, including simulation techniques for clinical trial design.
- Have working knowledge of CDISC standards, including SDTM and ADaM, and the ability to review and interpret statistical outputs.
- Have experience authoring and reviewing statistical analysis plans, protocol documentation, TLF shells, and other clinical development and regulatory deliverables.
- Understand GCP, ICH guidelines, and global regulatory requirements; contribute to regulatory submissions and health authority interactions.
- Have experience overseeing external vendors and ensuring statistical and biometrics deliverables are accurate, timely, high-quality, and compliant.
- Travel approximately 10% of the time and accommodate occasional evening or weekend work when required for critical study milestones.
- Preferred: Experience in radiopharmaceutical therapy or imaging drug development, global regulatory submissions, adaptive trial methodologies, or AI-enabled statistical workflows.
Responsibilities
- Lead biostatistical activities and develop statistical strategies, study designs, and analytical approaches for clinical oncology development programs.
- Provide statistical leadership across early-phase dose finding, dose optimization, pivotal trials, and registration-oriented studies.
- Prepare statistical briefing materials, respond to agency questions, and contribute to regulatory submission packages for health authorities including the FDA and EMA.
- Author and maintain statistical sections of clinical trial protocols, Statistical Analysis Plans, and Tables, Listings, and Figures shells.
- Collaborate with clinical development, statistical programming, data management, and regulatory teams to align deliverables and milestones.
- Review clinical trial data and identify efficacy, safety, and other clinically relevant trends.
- Review and validate study documentation, programming outputs, vendor deliverables, and analysis results for accuracy, quality, and regulatory compliance.
- Apply Bayesian methods and simulation techniques to support trial design and evidence generation.
- Oversee external vendors and biometrics service providers to ensure timely, high-quality, compliant deliverables.
- Pilot and support AI-enabled tools and workflows for statistical quality control and operational efficiency.
View Full Description & ApplyYou'll be redirected to the employer's site
