A.D. Biostatistics

North Davis Executive Search; Washington (District of Columbia); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading recruitment firm is seeking a Senior Biostatistician in Washington, DC. The role involves leading statistical activities in clinical trials across various therapeutic areas and requires a PhD in Biostatistics or Statistics with at least 4 years of experience. Candidates should have expertise in SAS and R, along with strong communication skills. This opportunity includes collaboration with cross-functional teams and managing statistical deliverables.

Qualifications

• Minimum 4 years of pharmaceutical clinical trial experience.
• In-depth knowledge of clinical trials methodology and regulatory requirements.
• Comprehensive experience with SAS programming and R/S language.

Responsibilities

• Lead statistician on multiple studies across different therapeutic areas.
• Provide statistical consultation and guidance to cross-functional teams.
• Manage CRO statisticians and internal biostatistics team.

Skills

SAS programming

R/S language

Collaboration

Communication skills

Education

PhD in Biostatistics or Statistics

Job description

Primary Responsibilities

• Leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR).
• Participate in study-related activities and provide statistical consultation, input and guidance to cross-functional groups.
• Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others.
• Manage CRO statisticians and internal biostatistics team, including junior statisticians, contract statisticians and programming team in support of biostatistics operational activities.
• Act as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate in activities related to regulatory requests and meetings as needed. Maintain close communication with the functional manager.
• Provide statistical expertise by identifying potential issues, offering recommendations and engaging external statistical experts as needed.

Requirements

• D. in Biostatistics or Statistics
• At least 4 years of pharmaceutical clinical trial experience
• In-depth knowledge of clinical trials methodology, regulatory requirements, and statistics
• Comprehensive experience with SAS programming and R/S language
• Ability to effectively collaborate in a dynamic environment
• Excellent practical, organizational, interpersonal, oral and written communication skills