Senior Clinical, Trial Biostatistician

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 13%

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Saratoga Ascend

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1985

🏥 Healthcare

🎯 Recruiter

🏛️ Government

Healthcare • Recruitment • Government

Saratoga Ascend is a federal- and state-focused healthcare workforce and solutions firm that connects cleared, credentialed healthcare professionals with government, military, and civilian healthcare facilities across the U. S. The company provides clinical and non-clinical staffing, clinical lab and scientific staffing, call center services, federal healthcare consulting, IT solutions, program and administrative support, and SLED (state, local, education) services. With a stated four-decade legacy, nationwide coverage, rapid-fill capabilities, strict credentialing/compliance processes, and operation under federal contract vehicles, Saratoga Ascend positions itself as a government-focused healthcare staffing and program management partner.

📋 Description

• Support clinical studies as a senior clinical/trial biostatistician • Design clinical studies, including small-population and early-phase studies • Develop statistical analysis plans and randomization schemes • Perform power and sample size calculations • Conduct interim and final analyses • Produce tables, listings and figures for DSMB reviews and regulatory submissions • Support preclinical studies • Contribute to protocols, reports and manuscripts • Support NIH- or FDA-regulated clinical research programs • Work alongside Government clinical investigators, regulatory staff and program officials in a multidisciplinary team

🎯 Requirements

• Ph.D. in biostatistics, statistics or a related quantitative field preferred • Master's degree with substantial equivalent experience acceptable • Minimum of 8 years of experience as a biostatistician on clinical studies (Ph.D.) or 10 years (master's), including NIH- or FDA-regulated trials • Clinical study design, including small-population and early-phase designs • Development of statistical analysis plans and randomization schemes • Power and sample size calculations • Interim and final analyses, and production of tables, listings and figures for DSMB reviews and regulatory submissions • Proficiency in SAS, R or equivalent statistical software • Experience supporting preclinical studies and contributing to protocols, reports and manuscripts • Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs • Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA • Current human subjects protections and GCP training (e.g., CITI or equivalent) • Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials

🏖️ Benefits

• Competitive rate • Benefit options • Equal opportunity employment

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