Senior Biostatistician

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

Description

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.

Duties and 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.

Minimum 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.

Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.

For more information on Venesco, LLC., visit https://venesco.com.