Biostatistics Associate Director

Vetted Solutions; Bridgeport (Montgomery County); On-site; USD 150,000 - 210,000; Full time

Job summary

Vetted Solutions seeks an Associate Director, Biostatistics to lead statistical support for clinical programs in innovative biotherapies and vaccines. You will design and oversee statistical components of trials and ensure regulatory compliance.

You will mentor biostatistics staff, develop analysis plans, and communicate results clearly to cross-functional teams to drive regulatory submissions and decision making, while advancing innovative statistical methods that strengthen evidence generation

Responsibilities

• Design and oversee statistical components of clinical trials, including protocol input.
• Perform sample size and power calculations.
• Develop and own statistical analysis plans.
• Guide biostatistics programming and data quality activities.
• Ensure compliance with ICH, FDA, EMA, and GCP standards.
• Interpret trial results and clearly communicate findings to cross-functional teams.
• Mentor and develop biostatistics staff.
• Contribute to regulatory submissions and support scientific/regulatory decision‑making.
• Advance innovative statistical methods that strengthen evidence generation for patient benefit.

Job description

Associate Director, Biostatistics leads statistical support for clinical programs in innovative biotherapies and vaccines.

• Design and oversee statistical components of clinical trials, including protocol input.
• Perform sample size and power calculations.
• Develop and own statistical analysis plans.
• Guide biostatistics programming and data quality activities.
• Ensure compliance with ICH, FDA, EMA, and GCP standards.
• Interpret trial results and clearly communicate findings to cross-functional teams.
• Mentor and develop biostatistics staff.
• Contribute to regulatory submissions and support scientific/regulatory decision‑making.
• Advance innovative statistical methods that strengthen evidence generation for patient benefit.