Senior Biostatistician
About this role
Description
Senior Biostatistician
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
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.
Company at a glance
Venesco, LLC is a premier government contractor delivering Healthcare, IT, Research & Development, and a range of mission‑critical services to federal agencies. For more than 18 years, we’ve evolved from a small consulting firm into a respected leader in biomedical R&D and IT support, backed by strong financials, mature processes, and a commitment to employee connectedness and work–life balance.
Our success is driven by our skilled professionals, agile management practices, and high‑quality standards. Venesco holds a Top‑Secret Facility Clearance and maintains CMMI® Maturity Level 3 (Services) and ISO 9001:2015 and 14001:2015 certifications. We’ve been recognized on the Inc. 5000 and Washington Technology’s Fast 50 lists for five consecutive years.
With more than 350 credentialed employees and 65+ prime contracts — ranging from small teams to programs with 150+ personnel — we deliver the impact of a large enterprise while maintaining the agility of a small business. Venesco continues to recruit motivated, talented individuals who want to contribute to meaningful federal initiatives and join a collaborative, high‑performing team.
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