GatedTalent - Connecting Top Executive Search Firms And Executives · 6 hours ago
Senior Director | Global Biostatistics | Remote
Newark, DE
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
10+ years exp
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Responsibilities
Develop and implement global policies, procedures, and standards for biostatistical operations.
Align biostatistical deliverables with FDA, EMA, PMDA, GCP, and ICH regulations.
Design and approve statistical analysis plans (SAPs), sample size justifications, and clinical trial protocols.
Partner with functional heads, site leaders, and clients across the organization’s international network to align biostatistics strategies with organizational goals.
Manage and develop a global team of biostatisticians, fostering professional growth and ensuring alignment with the organization’s objectives.
Represent the organization in client interactions, facility visits, and audits, showcasing our capabilities in biostatistics.
Provide technical and strategic leadership to enhance operational efficiency and clinical trial sophistication.
Qualification
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Required
In-depth knowledge of GCP, ICH, FDA regulations, and clinical drug development and approval processes
Experience interacting with regulatory agencies
Expertise in SAS, Phoenix WinNonlin, Kinetica, and advanced skills in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Strong written and verbal communication skills, with a command of medical terminology, scientific writing, and presentation development
Proven ability to manage and mentor teams in a global drug development environment
Direct experience in task assignment, performance management, and employment decisions
Skilled in assessing client needs, meeting quality standards, and ensuring client satisfaction under tight timelines and pressure
Demonstrated ability to thrive in global, cross-functional teams, employing active listening and fostering a collaborative work environment
A minimum of 10 years of relevant experience in the pharmaceutical or CRO industry
Preferred
An advanced degree in pharmaceutical research, biostatistics, or a related scientific field
Company
GatedTalent - Connecting Top Executive Search Firms And Executives
GatedTalent was established in 2017 in response to the need for a secure and sophisticated tool to allow individual executives to share information privately with executive recruiters while supporting GDPR compliancy.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Natalie Fitzpatrick
Executive Researcher
Recent News
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