Biostatistics Senior Manager

Job Summary

Leading sophisticated studies in the General Medicine therapeutic areas, the full-time remote Biostatistics Senior Manager will manage statistical aspects of clinical activities, provide statistical guidance, and collaborate with multidisciplinary teams to influence strategy development.

Key responsibilities

• Utilizing expertise to inform and provide statistical guidance for clinical development, reimbursement, and medical affairs
• Planning and executing statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs)
• Leading all aspects of work performed by study statisticians and performing statistical analysis of studies/projects

Required qualifications

• Doctorate degree in Statistics/Biostatistics or related subject with at least 2 years of Biostatistics experience, or equivalent qualifications
• Strong understanding of regulatory guidelines in drug development
• Experience with life cycle drug development (pre-clinical, clinical, and post-marketing)
• Proven leadership skills in motivating multi-functional teams to advance complex projects
• Strong working knowledge of theoretical and applied statistics