Biostatistician

About the Organization

The Bronchiectasis and NTM Association is dedicated to improving the lives of people affected by bronchiectasis and NTM lung disease. The Association is committed to advancing high-quality, specialized care, research, education, support, and advocacy within the bronchiectasis and NTM lung disease communities, helping people live longer, healthier lives. The COPD Foundation is a leading, mission-driven organization dedicated to advancing the understanding, treatment, and management of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, and NTM lung disease. Our mission is to help millions of people live longer, healthier lives by accelerating research, expanding advocacy, and increasing awareness. We foster a collaborative and innovative environment where experts work together to develop meaningful solutions that improve outcomes for patients worldwide.

Position Overview

The Biostatistician reports to the Senior Director of Clinical Trials Network (CTN)/Lead Biostatistician and provides statistical expertise across the Association's clinical trials and observational research programs. The role will contribute to study design, protocol development, Statistical Analysis Plans, data analysis, publications, and regulatory activities, while helping ensure high standards of statistical quality and reproducibility.

Key Responsibilities

• Lead and support statistical analyses for clinical trials and observational studies, including study design, sample size and power calculations, and interpretation of results.
• Develop Statistical Analysis Plans and perform and validate descriptive, inferential, epidemiological, longitudinal, and time-to-event analyses.
• Consult with investigators and industry partners on study design, research databases, analysis plans, and interpretation of study data.
• Manage data wrangling, analytic dataset creation, statistical programming, data visualization, and preparation of abstracts, manuscripts, and presentations.
• Oversee the Assistant Biostatistician and provide guidance on data management and analysis activities.
• Lead the CTN statistical quality program, including development and continuous improvement of statistical SOPs, templates, and quality control procedures.
• Ensure statistical activities comply with ICH-GCP, applicable regulatory guidance, and CTN quality standards.

Professional & Personal Competencies

• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Strong scientific writing, presentation, communication, and statistical interpretation skills.
• Highly organized, accurate, dependable, and detail-oriented, with the ability to manage multiple priorities.
• Ability to work effectively both independently and collaboratively in a remote environment.

Education & Experience

• Master's degree or equivalent in Epidemiology, Biostatistics, Data Science, or a related field.
• At least three years of post-graduate experience in clinical trials and biostatistics.
• Experience or interest in respiratory/pulmonary disease research is a plus but not required. Candidates with strong clinical research and biostatistics experience from any therapeutic area are encouraged to apply.
• Proficiency in SAS and R, with experience in REDCap Cloud or REDCap Academic.
• Experience with Git/version control and reproducible reporting tools such as R Markdown, Quarto, or SAS ODS.

Pay

$80K

Benefits

Full Time Benefits Overview

Location

Remote; ability to travel for job-related events, meetings, & conferences.