Full-Time Sr Manager, Biostatistics

Senior Manager of Biostatistics is a member of cross-functional development teams and contributes to: trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.

Key Responsibilities:

• Collaborates in design of clinical study including methodology, data analysis & interpretation, and reporting of study results.
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plans, case-report forms, clinical study reports, associated publications, and other study level specification documents.
• Performs and/or validates statistical analyses, advise ways to maximize clarity of data display.
• Communicates results to cross-functional teams, provides data interpretation in study documents such as clinical study reports, and publications.
• Translates scientific questions into statistical terms and statistical concepts into layman terms.
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable.
• Continuously develops technical knowledge of statistical methodology and how it is appropriately applied in trial design and data analysis for clear, concise, high-quality results.
• Continuously enhances knowledge of drug development process, regulatory and commercial requirement.
• Develops & advises team members.
• Effectively communicates the GBDS Mission and Vision.
• Enables a culture of inclusiveness, respect for diversity, compliance with process, and respectful challenging of others.

Qualifications & Experience:

• Fresh PhD or MS with 2+ years’ experience in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.
• Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
• Good interpersonal, communication, writing and organizational skills.
• Ability to learn regulatory requirements, clinical trial design, data analysis, interpretation, and to work within cross-functional teams.
• Ability to organize multiple work assignments and establish priorities.
• Experience in standard and advanced statistical methods preferred.
• Good understanding of regulatory requirements & clinical trial design preferred.

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