Associate Director Biostatistics

Emmes Group•Rockville, MD

88d•Remote

About The Position

The Associate Director, Biostatistics provides leadership and subject matter expertise for the statistical design, analysis, and interpretation of clinical trial data. This role works closely with cross functional teams including clinical operations, data management, medical writing, and regulatory affairs to ensure the integrity, accuracy, and scientific rigor of statistical analyses across multiple studies and therapeutic areas. The Associate Director contributes to the strategic planning of study design and provides guidance on statistical methodology, data analysis, and reporting to support clinical development programs.

Requirements

Master's Degree in Biostatistics, Statistics or a related scientific discipline or PhD in Biostatistics, Statistics, Mathematics, Epidemiology, or a related scientific discipline.
7-9 years experience in biostatistics within the pharmaceutical, biotechnology, or clinical research environment.
4-6 years Proven experience in clinical trial design, statistical programming, and data analysis.
4-6 years Experience supervising or leading a team of biostatisticians.
4-6 years Strong knowledge of statistical software such as SAS, R, or Python
4-6 years Familiarity with regulatory requirements and guidance from FDA, EMA, or other health authorities.
4-6 years Experience with global clinical trials and multi-center studies.

Responsibilities

Lead and oversee the statistical analysis plan SAP development, study design, and protocol development in collaboration with cross functional teams.
Supervise and mentor biostatisticians, providing technical guidance, training, and performance management.
Provide statistical input for study protocols, case report form CRF design, and data collection strategies.
Ensure high quality statistical deliverables, including tables, listings, figures, and clinical study reports.
Conduct complex statistical analyses using appropriate methodologies for clinical trials.
Review and approve statistical outputs, results, and programming code generated by team members.
Collaborate with medical writing, regulatory, and clinical teams to ensure accuracy and clarity of statistical content in submissions.
Support regulatory submissions and respond to queries from health authorities regarding statistical analyses.
Provide strategic input for study design, sample size calculations, and adaptive trial methodologies.
Drive process improvements and implementation of best practices in biostatistics.
Participate in department and corporate initiatives, including SOP development, quality assurance, and methodological advancements.
Performs other duties as assigned.
Complies with all policies and standards.