Biostatistics Associate Director, Clinical Trials

Azza HealthCare Agency; Bridgeport (Montgomery County); On-site; USD 190,000 - 240,000; Full time

Job summary

Azza HealthCare Agency seeks an Associate Director, Biostatistics to lead statistical support for clinical programs in biotherapies and vaccines. You will own statistical design and oversight of trial workstreams, including protocol input, sample size and power calculations, and SAP development.

This role also guides programming and data quality activities, ensuring adherence to ICH, FDA, EMA and GCP requirements, and interprets findings for cross-functional teams to inform decision-making and

Qualifications

• Strong expertise in clinical trial statistics and statistical analysis planning.
• Ability to lead and mentor biostatistics staff.
• Experience overseeing statistical programming and data quality.
• Knowledge of regulatory expectations and contribution to regulatory submissions.
• Competence in interpreting and presenting results to non-statistical teams.
• Commitment to compliant, science-driven work.

Responsibilities

• Lead statistical support for clinical programs in biotherapies and vaccines.
• Own statistical design and oversight of clinical trial workstreams, including protocol input.
• Oversee sample size and power calculations and SAP development.
• Guide programming and data quality activities and ensure adherence to ICH, FDA, EMA, and GCP requirements.
• Interpret and communicate statistical findings to cross-functional stakeholders for decision-ready reports.

Skills

Clinical trial statistics

Statistical analysis planning

Leadership and mentoring

Regulatory submission knowledge

Tools

Statistical programming

Data quality oversight

Job description

Azza HealthCare Agency seeks an Associate Director, Biostatistics to lead statistical support for clinical programs in biotherapies and vaccines. You will own statistical design and oversight of trial workstreams, including protocol input, sample size and power calculations, and SAP development.

This role also guides programming and data quality activities, ensuring adherence to ICH, FDA, EMA and GCP requirements, and interprets findings for cross-functional teams to inform decision-making and