Senior Biostatistician — Regulated Trials & FDA Submissions

Venesco,-LLC-; Frederick (MD); On-site; USD 140,000 - 190,000; Full time

Job summary

Venesco, LLC in Frederick, MD seeks 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.

The role requires a PhD in biostatistics or related field, 10+ years of regulated clinical research experience, and expertise in CDISC standards; you will mentor juniors and collaborate across functions.

Qualifications

• 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.

Skills

ICH E9 Knowledge

Education

PhD in Biostatistics, Statistics, Epidemiology, or related quantitative science

Job description

Venesco, LLC in Frederick, MD seeks 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.

The role requires a PhD in biostatistics or related field, 10+ years of regulated clinical research experience, and expertise in CDISC standards; you will mentor juniors and collaborate across functions.