Senior Biostatistician

VENESCO, LLC • Fort Detrick, MD

6d • $145,000 - $165,000

About The Position

Venesco LLC is seeking a Senior Biostatistician to provide statistical leadership for clinical and nonclinical studies by designing statistical methodologies, developing analysis plans, interpreting data, and supporting regulatory interactions and submissions.

Requirements

• PhD in Biostatistics, Statistics, Epidemiology, or related quantitative science.
• Minimum 10 years of biostatistics experience supporting regulated clinical research.
• Expertise in ICH E9 Statistical Principles for Clinical Trials.
• Experience supporting FDA submissions and regulatory interactions.
• Knowledge of CDISC standards and statistical programming environments.

Responsibilities

• Develop Statistical Analysis Plans (SAPs).
• Lead study design and sample size calculations.
• Provide statistical oversight of clinical studies.
• Review protocols and CRFs.
• Develop statistical methodologies and analysis strategies.
• Review statistical outputs and interpretation of results.
• Support FDA meetings and regulatory submissions.
• Respond to statistical questions from regulatory agencies.
• Mentor junior statisticians and programmers.
• Participate in cross-functional program reviews.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree